← Product Code OVO · P090002

# PINNACLE COMPLETE ACETABULAR HIP SYSTEM (P090002)

_DePuy Orthopaedics, Inc. · OVO · Jun 13, 2011 · Orthopedic · APWD_

**Canonical URL:** https://fda.innolitics.com/device/P090002

## Device Facts

- **Applicant:** DePuy Orthopaedics, Inc.
- **Product Code:** OVO
- **Decision Date:** Jun 13, 2011
- **Decision:** APWD
- **Device Class:** Class 3
- **Review Panel:** Orthopedic
- **Attributes:** Therapeutic

## Indications for Use

The Pinnacle® CoMplete® Acetabular Hip System is a single use device intended for uncemented fixation. The Pinnacle® CoMplete® Acetabular Hip System is intended as a primary joint replacement prosthesis in total hip arthroplasty for skeletally mature patients suffering at least moderate pain in the hip joint from non-inflammatory degenerative joint disease (NIDJD) and its composite diagnoses of osteoarthritis (OA) or post-traumatic arthritis. Pinnacle® CoMplete® Acetabular Hip System's inserts (Pinnacle® Ultamet®) are only intended for use with DePuy's femoral and acetabular components having matching outer and inner diameters.

## Device Story

The Pinnacle® CoMplete® Acetabular Hip System is a primary total hip replacement prosthesis. It consists of a cobalt-chromium-molybdenum (CoCrMo) metal insert (Pinnacle® Ultamet®) that fits into a titanium alloy (Ti6Al4V) acetabular shell, which is press-fit into the acetabulum. This shell articulates with a BIOLOX delta® ceramic femoral head attached to a titanium alloy femoral stem (S-ROM® or Summit™ Porocoat). The system is implanted by an orthopedic surgeon in a hospital setting. The device replaces the damaged hip joint to reduce pain and restore function. The healthcare provider uses the system to provide a stable, low-friction bearing surface. The device benefits patients by alleviating pain and improving mobility associated with degenerative joint disease. The system includes cancellous bone screws for additional fixation if required.

## Clinical Evidence

Prospective, multi-center, randomized, single-blind controlled study (IDE G050078) of 390 subjects comparing the Pinnacle® CoMplete® (COM) system to a metal-on-metal (MOM) control. Primary endpoint: composite success (clinical, radiographic, and revision criteria) at 24 months. Results: 92.2% success for COM vs 92.8% for MOM (non-inferiority p=0.007). Kaplan-Meier survivorship at 2.4 years was 98.9% for COM and 98.4% for MOM. No statistically significant differences in adverse events or Harris Hip Scores between groups.

## Technological Characteristics

Materials: CoCrMo alloy (ASTM F1537) insert, Ti6Al4V titanium alloy (ASTM F136/F620) shell/stem, BIOLOX delta® alumina ceramic femoral head. Sensing/Actuation: Mechanical bearing. Energy: None. Connectivity: None. Sterilization: Gamma irradiation (SAL 10^-6). Form factor: Modular hip prosthesis with 28mm/36mm head diameters. Surface: Porocoat® porous coating on shells and stems.

## Regulatory Identification

Intended as a primary joint replacement prosthesis in total hip arthroplasty.

## Submission Summary (Full Text)

> This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com.
>
> Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a PMA](https://innolitics.com/services/regulatory/), [a 510(k)](https://innolitics.com/services/510ks/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/).

{0}

SUMMARY OF SAFETY AND EFFECTIVENESS DATA (SSED)

I. GENERAL INFORMATION

Device Generic Name: Prosthesis, Hip, Semi-Constrained, Ceramic-on-Metal Articulation
Device Trade Name: Pinnacle® CoMplete® Acetabular Hip System
Applicant's Name and Address: DePuy Orthopaedics, Inc. 700 Orthopaedic Drive Warsaw, IN 46582
Date(s) of Panel Recommendation: August 18, 2009
Premarket Approval Application (PMA) Number: P090002
Date of FDA Notice of Approval: June 13, 2011
Expedited: Not applicable

II. INDICATIONS FOR USE

The Pinnacle® CoMplete® Acetabular Hip System is a single use device intended for uncemented fixation. The Pinnacle® CoMplete® Acetabular Hip System is intended as a primary joint replacement prosthesis in total hip arthroplasty for skeletally mature patients suffering at least moderate pain in the hip joint from non-inflammatory degenerative joint disease (NIDJD) and its composite diagnoses of osteoarthritis (OA) or post-traumatic arthritis.

Pinnacle® CoMplete® Acetabular Hip System's inserts (Pinnacle® Ultamet®) are only intended for use with DePuy's femoral and acetabular components having matching outer and inner diameters.

III. CONTRAINDICATIONS

The Pinnacle® CoMplete® Acetabular Hip System should not be implanted in patients with the following conditions:

- Active or recent joint or systemic sepsis
- Insufficient bone stock, osteoporosis, severe osteopenia
- Marked atrophy or deformity in the upper femur
- Skeletal immaturity, or where loss of musculature or neuromuscular disease would render the procedure unjustifiable

PMA P090002: FDA Summary of Safety and Effectiveness Data
page 1

{1}

- The presence of any known neoplastic or metastatic disease in the subject
- Chronic renal impairment or failure
- Known metal hypersensitivity
- Females of childbearing potential due to the unknown effects of potentially elevated metal ions on the fetus.

## IV. WARNINGS AND PRECAUTIONS

The warnings and precautions can be found in the Pinnacle® CoMplete® Acetabular Hip System labeling.

## V. DEVICE DESCRIPTION

The Pinnacle® CoMplete® Acetabular Hip System is comprised of a highly polished cobalt-chromium-molybdenum alloy (CoCrMo) metal insert (Pinnacle® Ultamet®) designed to fit within a compatible titanium alloy (Ti6Al4V) acetabular shell/cup which articulates with a compatible ceramic (BIOLOX delta® alumina) femoral head attached to a femoral stem as part of a primary total hip joint replacement system.

![img-0.jpeg](img-0.jpeg)

## Femoral Head

The BIOLOX delta® ceramic heads are available in 28mm and 36mm outer diameters with both 12/14 and 11/13 internal tapers. Each taper corresponds to a specific set of head sizes and neck offset lengths. Both the head and the liner articulating surfaces are highly polished to a minimum of 0.02μm Ra. The diametrical clearance of the 28mm and 36mm femoral head and the accompanying liners ranges from 40 - 160μm.

## Femoral Stems

The S-ROM® Modular Hip System includes both stems and sleeves made from titanium alloy. The femoral stems are manufactured from titanium alloy conforming to ASTM F136¹ or ASTM F620² dependent on femoral stem size. The S-ROM® femoral sleeve is

¹ASTM F136 Standard Specification for wrought Titanium-6 Aluminum-4 Vanadium ELI (extra low interstitial)
Alloy for Surgical Implant Applications

PMA P090002: FDA Summary of Safety and Effectiveness Data

{2}

manufactured from titanium alloy conforming to ASTM F136. The stems have a variety of neck lengths, lateral offsets, and head center heights. The stems are designed to interface with a femoral head implant at the proximal end, and with a sleeve for the S-ROM® system along the proximal end of the stem under the neck. The S-ROM sleeves contain the S-ROM coating and are available in a variety of shapes and sizes.

The Summit™ Porocoat tapered femoral stem system includes a press-fit porous coated hip stem made from titanium alloy (ASTM F620) in a range of sizes and in two styles: standard and high offset. The distal region of the main body is tapered and has a grit blast surface. The proximal region of the main body has a Porocoat® porous coating, which is also present on the acetabular shells.

## Metal Insert

The Pinnacle® Ultamet® Metal Inserts consist of a metal acetabular bearing insert manufactured from high carbon CoCrMo (ASTM F1537³). The bearing insert components are available with either 28mm or 36mm inner diameters, to accommodate the two different femoral head components and the compatible metal insert sizes for each of the femoral heads has a corresponding set of sizes to mate with the available acetabular shells.

## Acetabular Shell

The Pinnacle® Acetabular Cup System includes shells made from cast titanium alloy (ASTM F136) in a range of sizes and in three different styles: a 100 series, a 300 series, and a Sector series. The shells have a hole at the apex and an outer surface that has a Porocoat® porous coating.

The 100 Series style shells have a solid surface interface and are available in 44mm – 66mm (2mm increments) outer diameter sizes; the 300 series style shells have three spikes and are available in 44mm – 66mm (2mm increments) outer diameter sizes; and the Sector style shells have three holes at one side that can be used with fixation screws and are available in 44mm – 66mm (2mm increments) outer diameter sizes.

## Cancellous Bone Screws

The Pinnacle® CoMplete® Acetabular Hip System includes 6.5mm Pinnacle® cancellous bone screws that are manufactured of Ti-6Al-4V titanium alloy (ASTM F136) and are available in lengths ranging from 15 to 70mm. The self-tapping screws have four-point cutting flutes with a blunt tip. The screws also have a hex head and are inserted into the acetabulum using a hex screwdriver for additional fixation if necessary.

PMA P090002: FDA Summary of Safety and Effectiveness Data
page 3

{3}

System Compatibility
Below is a listing of all available components for use in the Pinnacle® CoMplete® Acetabular Hip System.

Table 1: Pinnacle® CoMplete® Acetabular Hip System Compatibility

|  Acetabular Cup  |
| --- |
|  Pinnacle 100 Acetabular Porocoat Cups 48mm - 66mm  |
|  Pinnacle 300 Acetabular Porocoat Cups 48mm - 66mm  |
|  Pinnacle Sector II Acetabular Porocoat Cups 48mm - 66mm  |
|  Metal Liner  |
|  28mm ID, 44 – 50mm OD  |
|  36mm ID, 50 – 66mm OD  |
|  Femoral Head  |
|  BIOLOX delta Ceramic Head 11/13 28mm and 36mm
(+0, +3, +6 heads only)  |
|  BIOLOX delta Ceramic Head 12/14 28mm
(+1.5, +5, +8.5 heads only)  |
|  BIOLOX delta Ceramic Head 12/14 36mm
(+1.5, +5, +8.5, +12 heads only)  |
|  Femoral Stem  |
|  Summit Porous standard offset  |
|  Summit Porous high offset  |
|  S-ROM stems and porous sleeves standard offset  |
|  S-ROM stems and porous sleeves high offset  |
|  Cancellous Bone Screws  |
|  6.5mm Pinnacle cancellous bone screws (15 – 70mm)  |

VI. ALTERNATIVE PRACTICES AND PROCEDURES

There are several other alternatives for the reduction or relief of pain due structural damage in the hip joint from non-inflammatory degenerative joint disease and its composite diagnoses of osteoarthritis or post-traumatic arthritis including:

- The use of other commercially available total hip replacement systems already approved or cleared by the FDA. Commonly used implant bearing materials for total hip arthroplasty include metal on ultra-high molecular weight polyethylene (UHMWPE), ceramic on UHMWPE, metal on metal, and ceramic on ceramic;
- Non-surgical treatment such as reduced activity and/or pain medication; and
- Other surgical treatments that do not involve the use of an implant such as a hip fusion.

Each alternative has its own advantages and disadvantages. A patient should fully discuss these alternatives with his/her physician to select the method that best meets expectations and lifestyle.

PMA P090002: FDA Summary of Safety and Effectiveness Data
page 4

{4}

# VII. MARKETING HISTORY

Use of the ceramic-on-metal articulation has been marketed outside of the United States since 2006. At the time of the PMA submission, the ceramic-on-metal system is being sold in over forty (40) countries. (Australia, Austria, Belgium, Canada, China, Cyprus, Czech Republic, Denmark, Dubai, Egypt, England, Estonia, Finland, Germany, Greece, Hong Kong, Hungary, India, Indonesia, Iran, Iraq, Israel, Italy, Korea, Latvia, Lithuania, Luxemburg, Malaysia, Malta, Netherlands, New Zealand, Northern Ireland, Pakistan, Philippines, Poland, Portugal, Republic of Ireland, Russia, Scotland, Singapore, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, Wales, and Vietnam). These devices have not been withdrawn from marketing in any country for reasons of safety and effectiveness.

# VIII. POTENTIAL ADVERSE EFFECTS OF THE DEVICE ON HEALTH

## Reported Device Related Adverse Effects

The most commonly reported adverse events related to the Pinnacle® CoMplete® Acetabular Hip System device are:

- Trochanteric bursitis
- Wound problems
- Musculoskeletal problems
- Dermatological problems
- Pain

## Potential Adverse Effects

The following adverse effects may occur in association with any hip replacement surgery, including the Pinnacle® CoMplete® Acetabular Hip System:

- Device failure, because the components cannot be expected to indefinitely withstand the activity level and loads of normal healthy bone.
- Surgical complications including, but not limited to: genitourinary disorders; gastrointestinal disorders; vascular disorders, including thrombus; bronchopulmonary disorders, including emboli; myocardial infarction or death.
- Hematoma or damage to blood vessels resulting in large blood loss.
- Delayed wound healing.
- Superficial or deep infection. Infections may occur months to years after surgery. These infections are difficult to treat and may require reoperation with removal surgery and replacement at a later time.
- Temporary or permanent nerve damage resulting in pain or numbness of the affected limb.
- Metal sensitivity reactions, allergic reactions, or metallosis.
- Dislocation and subluxation leading to postoperative joint instability (which may be caused by malpositioning of the implants or muscle/fibrous tissue laxity).

PMA P090002: FDA Summary of Safety and Effectiveness Data
page 5
LO

{5}

- Loosening of hip replacement components can occur. Early mechanical loosening may result from inadequate initial fixation, malalignment, latent infection, premature loading of the prosthesis, or trauma. Late loosening may result from trauma, infection, biological complications (including osteolysis), or mechanical problems, with the subsequent possibility of bone erosion and/or pain.
- Limb length discrepancy.
- Device related noise such as, clicking, popping, squeaking or grinding.
- Increased hip pain and/or reduced hip function.
- Fatigue fracture of the implants as a result of excessive loading, malalignment, or trauma.
- Osteolysis and/or other peri-prosthetic bone loss.
- Bone perforation or fracture (occurring either intra-operatively or occurring post-operatively as a result of trauma, excessive loading, osteolysis or osteoporosis).
- Periarticular calcification or ossification.
- Wear and deformation of the articular surface (as a result of excessive loading or implant malalignment).
- Pseudotumor.
- Aseptic Lymphocyte Dominated Vasculitis Associated Lesion (ALVAL).

Any of these adverse effects may require medical or surgical intervention. In rare cases, these adverse effects may lead to death. The potential long-term biological effects of metal wear debris and metal ion production are not known.

For the specific adverse events that occurred in the clinical studies, please see Section X below.

## IX. SUMMARY OF PRECLINICAL STUDIES

### A. Laboratory Studies

Non clinical laboratory testing was provided in support of the Pinnacle® CoMplete® Acetabular Hip System including the information regarding:

- Femoral Stem Component: stem fatigue strength
- Femoral Head Component: burst strength, fatigue strength, axial pull-off strength
- Acetabular Liner: locking strength
- Acetabular Bone Screws
- Bearing Couple: wear including micro-separation during the swing phase, ion level measurements, frictional torque, and range of motion; and
- Surface Coating Characterization

PMA P090002: FDA Summary of Safety and Effectiveness Data

{6}

1. **Femoral Stem Components**

**Femoral Stem Fatigue Strength**

Method: To determine fatigue performance of the smallest size S-ROM and Summit Porocoat femoral stems, testing was performed per FDA’s Guidance Document for Femoral Stem Prostheses⁴, in accordance with ISO 7206-4.

Results: Stems were tested at their respective endurance limits with no failures occurring to 5 million cycles. The results of these tests demonstrate that the femoral stem should withstand predicted *in vivo* loads.

2. **Femoral Head Component**

Worst Case Testing: Testing was conducted on the 28mm 12/14L taper and 28mm 11/13L taper BIOLOX delta heads because this size represents the smallest diameter femoral head with the longest neck length and results in the least amount of taper engagement with the femoral stem trunnion

**Pre-Fatigue Burst Strength**

Purpose: Static burst or 'crush' testing was performed to evaluate the ability of the individual ceramic head components to withstand static axial compression.

Method: Static burst testing was performed on 7 ball heads according to ISO 7206-10⁵

Acceptance Criteria: Average pre-fatigue burst strength shall exceed 46kN. No ball shall fail at less than 20kN according to FDA’s Guidance Document for the Preparation of Premarket Notifications for Ceramic Ball Hip Systems⁶

Results: The average pre-fatigue burst strength of the 28mm 12/14L taper was 95kN with no head fracturing below 80kN. The average pre-fatigue burst strength of the 28mm 11/13L taper was 61kN with no head fracturing below 42kN. The specimens tested met the acceptance criteria.

**Fatigue Strength**

Method: Fatigue testing of three 28 – 11/13 and three 28 – 12/14 taper Biolox delta ceramic ball heads on titanium alloy tapers was conducted. The applied load was cycled to a maximum of 14.0 to minimum of 0.5kN at a frequency of 10 Hz in Ringers solution at ambient temperature for 10 million cycles

Acceptance Criteria: All samples shall survive 10 million cycles with no macroscopically visible component failure, according to FDA’s Guidance Document for the Preparation of Premarket Notifications for Ceramic Ball Hip System

---

⁴ FDA’s Guidance Document for Industry and FDA Staff –Non-clinical Information for Femoral Stem Prostheses, September 17, 2007.

⁵ ISO 7206-10 Implants for surgery – Partial and total hip-joint prostheses – Determination of resistance to static load of modular femoral heads

⁶ FDA’s Guidance Document for the Preparation of Premarket Notifications for Ceramic Ball Hip Systems, January 10, 1995

PMA P090002: FDA Summary of Safety and Effectiveness Data
page 7
12

{7}

Results: All femoral head components survived 10 million cycles without failure

## Post-Fatigue Burst Strength

Method: Following fatigue testing, burst testing of the three 28 – 11/13 and three 28 – 12/14 taper Biolox *delta* ceramic ball heads was performed according to ISO 7206-10.

Acceptance Criteria: No post-fatigue fractures below 20kN, according to FDA’s Guidance Document for the Preparation of Premarket Notifications for Ceramic Ball Hip System

Results: The minimum post-fatigue burst strength of the 28mm 12/14L taper femoral head was 71kN and the minimum post-fatigue burst strength of the 28mm 11/13L taper femoral head was 66kN minimum. These values exceed the 20kN requirement for the post-fatigue burst strength suggested by the FDA Ceramic Ball Guidance.

## Axial Head Pull-off Strength

Method: Three 28 – 11/13 and three 28 – 12/14 taper Biolox *delta* ceramic ball heads were tested for pull-off loads according to FDA’s Guidance Document for the Preparation of Premarket Notifications for Ceramic Ball Hip Systems

Acceptance Criteria: Axial pull-off strength shall be greater than 250N

Results: The average axial pull-off strength of the 28mm 12/14L taper femoral head is 1369N and the average axial pull-off strength of the 28mm 11/13L taper femoral head is 1627N. The ceramic head testing results indicate that the ceramic heads possess sufficient strength to perform as intended under expected *in vivo* loading conditions.

## 3. Acetabular Liner

Worst Case: To capture the entire size range, test samples included the 28 x 48mm, 36 x 52mm, and 36 x 66mm liners. The metal liners were assembled into Pinnacle shells.

## Push-Out Force

Acceptance Criteria: Push-out force shall exceed 50 lbs

Method: For the push-out testing, two different methods of assembling the insert to the shell were used: compressive force or impaction.

Inserts of each size were initially assembled by the compressive force method and the push-out force was recorded. Those same inserts were then reassembled into their shells using the impaction assembly method and the push-out force was again recorded. Finally, three new samples of the 36 x 66mm liners were assembled using the impaction assembly method and the push-out force were recorded.

PMA P090002: FDA Summary of Safety and Effectiveness Data
page 8
VΔ

{8}

Results: Using the compressive assembly method, the minimum push-out force for the liners was 148.4lbs. Using the impaction assembly method, the minimum push-out force for the liners was 361.9 lbs. Using the new samples assembled using the impaction assembly method, the minimum push-out force of the insert was 483.3 lbs.

## Torque-Out Strength

Acceptance Criteria: Torque-out force shall exceed 53in-lbs

Method: The metal inserts were assembled into the shells using the compressive force method. The inserts were torqued out and the torque required to loosen the insert from the shell was recorded.

Results: The minimum torque-out force for the liners tested was 336.7 in-lbs.

## 4. Acetabular Bone Screws

### Torsional Strength

Method: Using a hex key, a torsional load was applied to the screw at a rate of 50lbf-in/min, while applying an axial compression load of 10lbf.

Results: The failure mode for all samples was the rounded hex, with a minimum peak torque of 90.7lb-in.

## 5. Bearing Couple

### Wear Testing

a. 28mm High Clearance Wear Simulation

Worst Case Rationale: In hard-on-hard bearings, the smallest bearing diameter generally represents the worst-case testing scenario. Therefore, to simulate the worst case scenario the smallest bearing (28mm) with the highest diametrical clearance allowed per the engineering drawings was tested.

Materials: BIOLOX delta heads articulating with metal Ultamet liners

Method: The wear test was performed on a 10-station hip joint simulator using the Paul-type physiological loading (3000 N max loading cycle, ± 23° biaxial rocking motion at 1 Hz). The interface was lubricated with 25% bovine serum. The wear test was run for a total of 5 million cycles.

Results: The mean bedding-in wear rate (taken to be 0 – 1.5M cycles) was 0.11mm³/10⁶ cycles and the mean steady state wear rate (taken to be 1.5 – 5M cycles) was 0.01mm³/10⁶ cycles.

b. 36mm Wear Simulation

Materials: BIOLOX delta heads articulating with metal Ultamet liners

Method: The cups were mounted anatomically above the heads at an angle of 35° to the horizontal. The synchronized load and motion cycles were applied at 1 Hz.

PMA P090002: FDA Summary of Safety and Effectiveness Data

{9}

The load cycle was a dual-peak cycle with maximum of 3kN, the valley of 1kN and swing phase load of approximately 50N which is applied over 40% of the cycle. The motion applied was +30°/-15° on the swing and ±10° on the internal/external rotation with sinusoidal curves as a simplified cycle. The bearings were immersed in a 25% new-born calf serum solution throughout the test.

Results: The mean bedding-in wear rate, (taken to be from 0 to 1.5M cycles) for the 36mm ceramic-on-metal bearing was 0.095 mm³/10⁶ cycles. The mean steady state wear rate for the bearing was 0.02mm³/10⁶ cycles.

c. 36mm Wear Simulation Using Scratched Cups

Method: The 36mm bearings were previously tested on the hip simulator to 5 million cycles as described in (b.) above and deemed to be fully bedded in. Following the wear testing, the liners were scratched with a diamond stylus to simulate potential in vivo damage. The wear simulation was then continued for 5 million cycles on the scratched liners using the same loading protocol.

Results: The results showed no component failures out to 10 million cycles. After the metal liners had been scratched the ceramic-on-metal bearings had an average steady state wear rate of 0.001 mm³/10⁶ cycles.

d. 28mm Micro-Separation Simulation

Materials: BIOLOX forte ceramic head articulating with Ultima metal insert. The Ultima liner follows the same manufacturing specifications as the Ultamet liner; however the surface roughness and spherical diameter are different. The BIOLOX forte ceramic head articulating with metal underwent wear testing that demonstrated this combination produced wear at a higher rate than the BIOLOX delta combination. This makes the BIOLOX forte articulating with the Ultima liners a more worst-case scenario. Please note the BIOLOX forte ceramic femoral heads are not a compatible component of the Pinnacle® CoMplete® Acetabular Hip System.

Method: The components were tested in a 10-station hip simulator. The wear test introduced micro-separation of the femoral head compared to the insert ranging from 0 – 4mm for each component. The tests were carried out in 25% bovine serum; all stations were run at 1 Hz for 5 million cycles.

Results: The ceramic-on-metal bearing pair had an average wear rate of 0.256mm³/10⁶ cycles.

e. 28mm Debris Morphology Simulation

Materials: BIOLOX forte ceramic head articulating with Ultima metal insert. The Ultima liner follows the same manufacturing specifications as the Ultamet liner; however the surface roughness and spherical diameter are different. The BIOLOX forte ceramic head articulating with metal underwent wear testing that

PMA P090002: FDA Summary of Safety and Effectiveness Data

{10}

demonstrated this combination produced wear at a higher rate than the BIOLOX delta combination. This makes the BIOLOX forte articulating with the Ultima liners a more worst-case scenario. Please note the BIOLOX forte ceramic femoral heads are not a compatible component of the Pinnacle® CoMplete® Acetabular Hip System.

Method: The implants were tested in a physiological hip joint simulator with the cup in the superior position to the head and inclined in the anatomical position at 45° to the vertical axis. A single axis twin peak Paul type loading curve was applied. Two directions of motion were applied, flexion-extension and internal-external rotation. The motions were 90° out of phase. Tests were carried out in 25% bovine serum; the implants were tested for 5 million cycles.

Results: Majority of the particles were oval to round in shape, and appeared as clumps or aggregates when observed using transmission electron micrographs, which may have occurred during sample preparation. The mean particle sizes at one million cycles were 17.57 ± 1.37nm and at five million cycles the mean particle sizes were 6.11 ± 0.40nm.

## Ion Level Testing

a. Measurement of Ion release in serum – 28mm bearing

Purpose: To compare the levels of Co, Cr and Mo ions released into serum from COC, COM (forte/Ultima), and MOM bearings during hip simulator testing under micro-separation conditions.

Materials: The 28mm bearing described in the Micro-Separation Wear Simulation summary above, were used to measure ion release

Method: Serum from the hip simulator test ran to determine micro-separation was prepared in the following way: 20ml of serum for each bearing type was taken at 1.7Mcycles and centrifuged at 1500rcf for 50 minutes, approximately 5ml of the mixture was sent for analysis.

Samples were analyzed in the following way: Levels of Co and Cr in the supernatant measured using graphite furnace atomic absorption spectroscopy; Mo ions were determined by inductively coupled plasma mass spectrometry

Results: The results (Table 2) demonstrated that serum cobalt, chromium and molybdenum ion levels from the COM bearing combination were lower than the corresponding MOM levels by a factor of at least 5.

PMA P090002: FDA Summary of Safety and Effectiveness Data
page 11
16

{11}

Table 2: Metal Ion Concentrations – 28mm bearing

|  Type | Cr (μg/L) | Co (μg/L) | Mo (μg/L)  |
| --- | --- | --- | --- |
|  MOM | 714 | 2079 | 257  |
|  COC | 6.15 | 0.62 | 1.7  |
|  COM | 140.8 | 317.7 | 4.3  |

b. Measurement of Ion release in serum – 36mm bearing

Materials: The 36mm bearing surface described in 36mm Wear Simulation above, were used to measure ion release

Method: Serum lubricant samples were taken for each bearing combination during both the bedding-in and steady-state periods. The lubricating serum was analyzed for levels of cobalt, chromium and molybdenum ions using inductively coupled plasma mass spectrometry.

Results: The average Cr ion levels measured were 26.0 μg/L (bedding-in) and 11.4 μg/L (steady-state); Co ion levels were 110.8 μg/L (bedding-in) and 38.5 μg/L (steady-state) and Mo ion levels were 16.0 μg/L (bedding-in) and 9.1 μg/L (steady-state).

We expected that the ceramic-on-metal bearing would exhibit metal ion concentration levels somewhere between MOM and COC bearings as demonstrated by the non-clinical mechanical testing. It should be noted that although high concentration of metal ions were observed *in vitro*, the simulations were under micro-separation conditions and the metal ion levels were collected over the span of the testing; thus not accounting for any filtering of metal ions as would be seen clinically. In addition the device has been contraindicated in patients with renal insufficiency; therefore patients should be able to adequately filter metal ions released by the device.

The *in vivo* clinical analysis of metal ion concentrations, also performed by the applicant in a subset of patients enrolled in the pivotal study does not correlate with the theory that metal ion levels from the COM bearing would be statistically less than the MOM bearing. The *in vivo* clinical results demonstrate that the metal ion concentration of the COM bearing is not statistically different than the metal ion concentration in MOM bearings.

Therefore, the results of the *in vitro* simulation have not been shown to correlate with clinical device performance. As a result, we asked the applicant to examine the survivorship of the COM and MOM bearings as reported in national joint registries. (see X.D.1.3 – Kaplan-Meier Survivorship Analysis); the applicant will also be monitoring long term *in vivo* metal ion levels in subjects enrolled in the metal ion study through a post-approval study (see XIII - CDRH Decision).

PMA P090002: FDA Summary of Safety and Effectiveness Data
page 12

{12}

# Frictional Torque Testing

Acceptance Criteria: The torque generated by the bearing couple was compared to the results of other hard-on-hard total hip replacement bearings.

a. 28mm flexion/extension unworn

Method: Components were tested with a flexion-extension motion of ±25° applied to the femoral head. Tests were performed at 1Hz, with a simple sinusoidal waveform through 60% of each cycle to apply a dynamic load, with a peak load of 2kN, and a swing phase load of 25N, 100N and 300N. Water, 25% (v/v) and 100% newborn bovine serums were used as lubricants. Each test was performed in a forward, and a reverse direction, and a mean taken. Lubricant was removed, and the prostheses cleaned between each test.

Results: In all lubricants tested and at all swing phase loads tested the mean friction factor for the ceramic-on-metal bearing couple are summarized below in Table 3:

Table 3: Friction Factor during flexion/extension – 28mm unworn bearing

|  100% Serum  |   |   |   |   |
| --- | --- | --- | --- | --- |
|   |  | 25N | 100N | 300N  |
|  COM bearing | Mean (95% CI of Mean) | 0.052 (0.006) | 0.065 (0.012) | 0.065 (0.013)  |
|  25% Serum  |   |   |   |   |
|  COM bearing | Mean (95% CI of Mean) | 0.040 (0.008) | 0.047 (0.010) | 0.049 (0.010)  |
|  Water  |   |   |   |   |
|  COM bearing | Mean (95% CI of Mean) | 0.015 (0.006) | 0.017 (0.008) | 0.021 (0.017)  |

95% CI of mean refers to the 95% confidence interval

b. 36mm flexion/extension unworn

Method: Components were tested in an inverted position, with a flexion-extension motion of ±25° applied to the femoral head. Tests were performed at 1Hz, with a simple sinusoidal waveform through 60% of each cycle to apply a dynamic load, with a peak load of 2kN, and a swing phase load of 300N. Lubricants were 100% bovine serum and water. Each test was performed in a forward, and reverse direction, and a mean taken.

Results: In all lubricants tested the mean friction factor for the ceramic-on-metal bearing couples are summarized below in Table 4:

PMA P090002: FDA Summary of Safety and Effectiveness Data

{13}

Table 4: Friction Factor, Frictional Torque – 36mm flexion/extension unworn

|  Bearing Combination |  | WATER |   | 100% SERUM  |   |
| --- | --- | --- | --- | --- | --- |
|   |   | Friction Factor | Frictional Torque (Nm) | Friction Factor | Frictional Torque (Nm)  |
|  low clearance | Mean (95% CI of Mean) | 0.031 (0.007) | 1.077 (0.281) | 0.084 (0.022) | 3.06 (0.69)  |
|  high clearance | Mean (95% CI of Mean) | 0.03 (0.006) | 1.034 (0.128) | 0.085 (0.011) | 3.03 (0.38)  |

95% CI of mean refers to the 95% confidence interval

c. 28mm flexion/extension worn

Method: Implants were loaded with a dynamic loading curve for normal walking since walking is the most frequent daily dynamic loading mode of the hip joint. The cycle time was varied between 0.5, 1 and 2 seconds. Additionally, the back swing load (minimum load) of 250N at 86% of the cycle was reduced to 100N and increased to 500N. Bearing pairs labelled “worn” were subjected to 5 million loading cycles in a hip simulator before friction testing began.

Results: In all lubricants tested the mean friction factor for the ceramic-on-metal bearing couples are summarized below in Table 5 (SD = standard deviation):

Table 5: Friction Moment during flexion/extension – 28mm worn bearing

|  Maximum Friction Moment for Different Back Swing Loads in Serum  |   |   |   |   |
| --- | --- | --- | --- | --- |
|   |  | 100 N | 250 N | 500 N  |
|  Implant | Wear Status | Mean ± SD (Nm)  |   |   |
|  COM – 28mm | unworn | 1.7 ± 0.4 | 2.1 ± 0.3 | 2.3 ± 0.3  |
|   |  worn | 2.4 ± 0.3 | 2.5 ± 0.4 | 2.6 ± 0.3  |
|  Maximum Friction Moment for Different Movement Frequencies in Serum  |   |   |   |   |
|   |  | 0.5 Hz | 1.0 Hz | 2.0 Hz  |
|  Implant | Wear Status | Mean ± SD (Nm)  |   |   |
|  COM – 28mm | unworn | 2.3 ± 0.3 | 1.9 ± 0.4 | 1.9 ± 0.4  |
|   |  worn | 2.8 ± 0.3 | 2.4 ± 0.2 | 2.2 ± 0.2  |
|  Maximum Friction Moment for Different Resting Duration in Serum  |   |   |   |   |
|   |  | 10 seconds | 30 seconds  |   |
|  Implant | Wear Status | Mean ± SD (Nm)  |   |   |
|  COM – 28mm | unworn | 2.1 ± 0.4 | 2.0 ± 0.4  |   |
|   |  worn | 2.6 ± 0.4 | 2.4 ± 0.2  |   |
|  Maximum Friction Moments in Serum Averaged Over All Variables  |   |   |   |   |
|  Implant | Wear Status | Mean (Nm) | SD (Nm)  |   |
|  COM – 28mm | unworn | 2.1 | 0.4  |   |
|   |  worn | 2.5 | 0.3  |   |

PMA P090002: FDA Summary of Safety and Effectiveness Data

{14}

d. 28mm internal/external rotation worn

Method: The dynamic torque profile was measured for constant cyclic torsional rotation amplitude of ± 20°. A cyclic axial force as applied in phase with the motion, to simulate the joint load during gait. Bearing pairs labelled "worn" were subjected to 5 million loading cycles in a hip simulator. Loading was designed to simulate walking from stand-still to measure the start-up torque peak, and also the mean peak torque over 20 cycles. Therefore the displacement was started 100ms before the load cycle in order to simulate the start of walking from stand-still and a preload force of 650N was applied to simulate the joint load for 2 legged stance. The magnitude of the peak applied force was 2000N. The loading frequency of 1Hz is generally assumed for walking. This also was halved and doubled to investigate the effect of loading rate for 0.5Hz, 1Hz, and 2Hz. The magnitude measured for walking is 250N and the value on either side was also applied to investigate 100N, 250N, and 500N. For this experiment the resting durations of 10s and 30s were compared.

Results: In all testing conditions the maximum torque for the ceramic-on-metal bearing couples are summarized below in Table 6:

Table 6: Maximum Torque – 28mm worn bearing

|  Maximum Torque in Serum Averaged Over All Variables  |   |   |   |   |
| --- | --- | --- | --- | --- |
|  Implant | Wear Status | Mean (Nm) | SD (Nm)  |   |
|  COM – 28mm | unworn | 0.49 | 0.04  |   |
|   |  worn | 0.49 | 0.04  |   |
|  Maximum Torque in Water Averaged Over All Variables  |   |   |   |   |
|  Implant | Wear Status | Mean (Nm) | Std (Nm)  |   |
|  COM – 28mm | unworn | 0.06 | 0.01  |   |
|   |  Worn | 0.22 | 0.03  |   |
|  Maximum Torque for Different Movement Frequencies in Serum  |   |   |   |   |
|   |  | 0.5 Hz | 1.0 Hz | 2.0 Hz  |
|  Implant | Wear Status | Mean ± SD (Nm) | Mean ± SD (Nm) | Mean ± SD (Nm)  |
|  COM – 28mm | unworn | 0.48 ± 0.03 | 0.49 ± 0.04 | 0.51 ± 0.06  |
|   |  worn | 0.55 ± 0.03 | 0.49 ± 0.04 | 0.54 ± 0.05  |
|  Maximum Torque for Different Back Swing Loads  |   |   |   |   |
|   |  | 100N | 250N | 500N  |
|  Implant | Wear Status | Mean ± SD | Mean ± SD | Mean ± SD  |
|  COM – 28mm | unworn | 0.34 ± 0.11 | 0.49 ± 0.04 | 0.51 ± 0.51  |
|   |  worn | 0.40 ± 0.02 | 0.49 ± 0.04 | 0.58 ± 0.01  |

SD = standard deviation

PMA P090002: FDA Summary of Safety and Effectiveness Data

{15}

# Range of Motion

Worst Case: The Summit Size 10 Stem is worst-case for impingement since it has the largest neck geometry. However it was unclear whether the standard or high offset stem option would be the worst-case scenario, therefore the analysis was performed on both offset options.

The size 30 standard S-ROM® femoral stem was selected as the worst-case femoral component since it provides the largest neck geometry with the least offset of all S-ROM stems. The largest available mating sleeve used with the S-ROM® stem is the size 18F XXL.

Method: Range of motion was evaluated using CAD models following a procedure that is based on that which is outlined in ISO 21535.

Acceptance Criteria: As outlined in ISO 21535 “Specific Requirements for Hip-joint Replacement Implants” the minimum allowable angle of flexion/extension is 100°, abduction/adduction is 60° and internal/external rotation is 90°.

Results: For the Summit Size 10 standard offset the worst case flexion/extension motion was 138°, the worst case abduction/adduction motion was 133°, and the worst case internal/external rotation motion was 217°. For the Summit Size 10 high offset the worst case flexion/extension motion was 140°, the worst case abduction/adduction motion was 132°, and the worst case internal/external rotation motion was 212°. For the S-ROM stem the worst case flexion/extension motion was 134°, the worst case abduction/adduction motion was 93.5°, and the worst case internal/external rotation motion was 186°.

## 6. Surface Coating

### S-ROM Coating

Method: The coating was characterized with regard to coating thickness, bead morphology, pore size, porosity, and bond strength characteristics and outlined in FDA’s Guidance Document for Testing Orthopedic Implants with Modified Metallic Surfaces Apposing Bone or Bone Cement⁷, dated April 28, 1994.

Results: The results of the coating characterization are summarized below in Table 7:

PMA P090002: FDA Summary of Safety and Effectiveness Data
page 16
21

{16}

PMA P090002: FDA Summary of Safety and Effectiveness Data
page 17

Table 7: S-ROM Coating Characterization

|  Mean Coating Thickness | 229 μm  |
| --- | --- |
|  Bead Shape | Spherical  |
|  Mean Pore Diameter | 125 μm  |
|  Mean Volume Percent Porosity | 34%  |
|  Mean Shear Strength | 46.1 MPa  |
|  Mean Tensile Pull-off Strength | 70.0 MPa  |

## Porocoat Porous Coating

Acceptance Criteria: The criteria for porous-coated components are described in FDA’s Guidance Document for Testing Orthopedic Implants with Modified Metallic Surfaces Apposing Bone or Bone Cement, dated April 28, 1994.

Method: The porous coating was characterized with regard to coating thickness, bead morphology, pore size, porosity, and bond strength characteristics.

Results: The results of the porous coating characterization are summarized below in Table 8:

Table 8: Porocoat Porous Coating Characterization

|  Mean Coating Thickness | 762 μm  |
| --- | --- |
|  Bead Shape | Spherical  |
|  Mean Pore Diameter | 275 μm  |
|  Mean Volume Percent Porosity | 51%  |
|  Mean Shear Strength | 25.5 MPa  |
|  Mean Tensile Pull-off Strength | 21.1 MPa  |

## B. Animal Studies

No animal studies have been performed. Animal studies were not deemed necessary to determine the safety and effectiveness of the Pinnacle® CoMplete® Acetabular Hip System.

## C. Additional Studies

### Biocompatibility

The materials for use in the Pinnacle® CoMplete® Acetabular Hip System are standard materials used in permanently, implanted orthopaedic implants, including cobalt-chromium-molybdenum alloy (ASTM F1537), titanium alloy (ASTM F136, ASTM F620,) and BIOLOX delta ceramic.

{17}

# Sterilization

The components of the Pinnacle® CoMplete® Acetabular Hip System are sterilized by gamma irradiation (Cobalt 60 source). The sterilization process has been validated to achieve a sterility assurance level (SAL) of $10^{-6}$ at a minimum dose of $25\mathrm{kGy}$ (2.5 Mrad) in compliance with the requirements of ISO 11137-1⁸. The product is not labeled "pyrogen free". The components are packaged in an inner and outer Tyvek pouch to maintain sterility.

# Shelf-Life

Shelf life testing was performed to verify sterile packaging integrity equivalent to five years for the S-ROM femoral stems and to ten years for all other components.

# X. SUMMARY OF PRIMARY CLINICAL STUDY

The applicant performed a clinical study to establish a reasonable assurance of safety and effectiveness of total hip replacement with the Pinnacle® CoMplete® Acetabular Hip System for skeletally mature patients suffering severe pain and disability due to structural damage in the hip joint from non-inflammatory degenerative joint disease (NIDJD) and its composite diagnoses of osteoarthritis (OA) or post-traumatic arthritis in the US under IDE G050078. Data from this clinical study, along with a *post hoc* subgroup analysis of only the subset of components the applicant is proposing to market (DePuy S-ROM and Summit Porocoat femoral stems, DePuy Pinnacle Sector II Porocoat, and Pinnacle 100 and 300 Series Porocoat acetabular cups), were the primary basis for the PMA approval decision. A summary of the clinical study is presented below.

## A. Study Design

Patients were treated from August 2005 – October 2006. The first surgery was performed on August 4, 2005 and the final surgery was performed on October 10, 2006. The database for this PMA reflected data collected through November 25, 2008 and included 390 subjects. There were 11 investigational sites.

The study was a prospective, multi-center, randomized, single blind, controlled clinical investigation of 390 procedures in 390 subjects comparing the Pinnacle® CoMplete® Acetabular Hip System (COM), the investigational ceramic-on-metal hip system, to a legally marketed metal-on-metal (MOM) articulation system. The study was designed to demonstrate non-inferiority between the investigational and control patient populations using a non-inferiority margin of $8\%$.

Both treatment groups received a commercially-available femoral stem. The control group was an active treatment with a legally marketed alternative bearing with similar indications for use.

PMA P090002: FDA Summary of Safety and Effectiveness Data
page 18

{18}

Femoral stem components used in this investigation consisted of implantations with Summit™ Porocoat, Summit™ DuoFix, S-ROM®, Prodigy™, and AML systems. Pinnacle 100, Pinnacle 300 and Pinnacle Sector II acetabular cups were used. Commercially available 28mm and 36mm Biolox® ceramic femoral heads were used on all femoral stems. In PMA P090002, for the Pinnacle® CoMplete® Acetabular Hip System the applicant is only seeking marketing approval for the following subset of the components studied in the IDE: S-ROM and Summit Porocoat femoral stems; and, Pinnacle 100, 300, and Sector II acetabular cups.

## 1. Clinical Inclusion and Exclusion Criteria

Enrollment in the study was limited to patients who met the following inclusion criteria:

- Able to (or capable of) provide consent to participate in the clinical investigation prior to the day of the surgery. However, if the informed patient consent was signed on the day of surgery, then the source documents needed to state that the subject was given adequate time prior to the date of surgery to review and give consent
- Skeletally mature (tibial and femoral epiphyses are closed) and 20 – 75 years of age at the time of surgery
- Undergoing cementless primary hip replacement surgery for non-inflammatory degenerative joint disease (NIDJD). Composite diagnoses of NIDJD include osteoarthritis, avascular necrosis, post traumatic arthritis, slipped capital femoral epiphysis (SCFE), fracture of the pelvis, and developmental dysplasia,
- Affected hip has a Harris Hip Score of ≤ 70, and a Pain rating of ≥ Moderate,
- Met the following selected radiographic parameters:
a. X-ray evaluation confirms the presence of NIDJD
b. Femoral and acetabular bone stock is sufficient regarding strength and shape, and is suitable to receive the implants
c. No structural bone grafts required to support the prosthetic component(s) or to shape the bone to receive the implant(s)
- Were willing to have knowledge of treatment arm (CoM or MoM) withheld for a period of 24 months postoperatively (unless disclosure is legally and/or medically necessary)
- Previous THA in contralateral hip is greater than one (1) year post-operative and had a Harris Hip pain rating less than Mild

Patients were not permitted to enroll in the study if they met any of the following exclusion criteria:

- Bilateral hip disease with an anticipated need for bilateral hip implant during study participation (i.e., within the next 24 months)
- THA required for the revision of previously failed THA
- Suffering from inflammatory arthritides (e.g., rheumatoid arthritis, juvenile rheumatoid arthritis, psoriatic arthritis, systemic lupus erythematosus, etc.)

PMA P090002: FDA Summary of Safety and Effectiveness Data
page 19

{19}

- Presence of a previous prosthetic hip replacement device (any type, including surface replacement arthroplasty, endoprosthesis, etc.) in the hip joint to be operated
- Previous Girdlestone procedure (resection arthroplasty) or surgical fusion of the hip to be operated,
- Above knee amputation of the contralateral and/or ipsilateral leg,
- Known allergy to metal (e.g. jewelry)
- Evidence of active infections that may spread to other areas of the body (e.g., osteomyelitis, pyogenic infection of the hip joint, overt infection, etc.)
- The presence of highly communicable disease or diseases that may limit follow-up (e.g., immuno-compromised conditions, hepatitis, active tuberculosis, etc.)
- Presence of known metastatic or neoplastic disease
- Significant neurologic or musculoskeletal disorders or disease that may adversely affect gait or weight bearing (e.g., muscular dystrophy, multiple sclerosis)
- Conditions that may interfere with the total hip arthroplasty’s survival or outcome (e.g., Paget’s disease, Charcot’s disease)
- Unwilling or unable to comply with a rehabilitation program for a cementless total hip replacement or who indicates difficulty or inability to return for follow-up visits prescribed by the study protocol
- Known to be pregnant, a prisoner, mentally incompetent, and/or alcohol or drug abuser
- Previous treatment for renal disease
- Any current systemic steroid therapy, excluding inhalers, or within three months prior to surgery

## 2. Follow-up Schedule

All subjects were scheduled to return for follow-up examinations at 4 weeks, 3 months, 12 months, 24 months and annually thereafter, unless otherwise indicated by complications.

Preoperatively, a complete medical history, Harris Hip Score and subject-reported visual analog scale to assess pain were collected.

Postoperatively at each follow-up visit, a Harris Hip Score, subject self-reported pain assessment and 3 radiographic views (anteroposterior pelvis, anteroposterior femur and lateral femur) were obtained. In addition, beginning at 12 months postoperatively, subject reported satisfaction outcomes were collected. Adverse events and complications were recorded at all visits.

On a subset of subjects, chromium, cobalt, and titanium ions were measured preoperatively, and at 3 months, 12 months and 24 months postoperatively.

Radiographs were reviewed by an independent radiographic reviewer.

PMA P090002: FDA Summary of Safety and Effectiveness Data
page 20

{20}

The key time points that were used in the study are shown below in the tables summarizing safety and effectiveness.

## 3. Clinical Endpoints

Per protocol, all subjects were evaluated at the 24 month endpoint.

With regard to safety, the following data were collected on all subjects: revisions adverse events, and survivorship.

With regard to effectiveness, the following data were collected on all subjects:

- Primary Outcomes: Harris Hip Scores, Radiographic Outcomes;
- Secondary Outcomes: Visual Analogue Scale scores for pain (VAS), and Subject Self-Reported Satisfaction and Function.

With regard to success/failure criteria, subject composite success or failure was determined at 24 months based upon a combination of clinical, radiographic, and revision criteria. A subject was considered to be a success if all of the following were met at the 24 month endpoint.

### Clinical Criteria for Success:

- Harris Hip total score ≥ 80 points.
- Harris Hip Pain was Mild or better.

### Radiographic Criteria for Success:

- Femoral stem subsidence, compared to 4 week baseline ≤ 2 mm.
- Acetabular shell migration, compared to 4 week baseline ≤ 2 mm.
- Acetabular shell inclination change, compared to 4 week baseline ≤ 4 degrees.
- Acetabular or femoral osteolytic lesions ≤ 5 mm in the greatest dimension.
- Acetabular or femoral radiolucencies involving ≤ 50% of the visible porous coated surface of the femoral stem or acetabular cup.

Revision Criteria for Success: No component removal. In addition, any subject that underwent a reoperation where any device component (acetabular or femoral components) was removed or replaced was considered a revision; and classified as a failure.

## 4. Subset Cohort of S-ROM and Summit Porocoat Stems

The applicant is only currently seeking marketing approval for the Summit Porocoat femoral stem (standard and high offset) and the S-ROM femoral stem as components for the Pinnacle® CoMplete® Acetabular Hip System. Among the 390 subjects enrolled in the IDE study, 226 received a S-ROM or Summit Porocoat stem. Various analyses were carried out on this Subset Cohort in addition to analyses on the all enrolled cohort.

PMA P090002: FDA Summary of Safety and Effectiveness Data

{21}

# 5. Bilateral Patients

Per study protocol, a bilateral patient is defined as an individual that receives a contralateral hip during the study period.

# B. Accountability of PMA Cohort

## All Enrolled Cohort

At the time of the applicant’s database lock, complete 24 month postoperative data (study endpoint) was available on 85% (85% of COM subjects and 85% of MOM subjects) of the 390 enrolled subjects in the IDE study.

This is summarized in Table 9 below.

Table 9: Patient Accounting for the All Enrolled Cohort

|   | PreOp |   | 4 Week |   | 3 Month |   | 12 Month |   | 24 Month  |   |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
|   | COM | MOM | COM | MOM | COM | MOM | COM | MOM | COM | MOM  |
|  TFU | 194 | 196 | 194 | 196 | 194 | 196 | 194 | 196 | 194 | 196  |
|  Deaths (cumulative) | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 2 | 0 | 2  |
|  Component Removal (cumulative) | 0 | 0 | 1 | 1 | 1 | 1 | 1 | 2 | 2 | 3  |
|  EFU | 194 | 196 | 193 | 195 | 193 | 195 | 193 | 192 | 192 | 190  |
|  AFU | 194 | 196 | 186 | 186 | 174 | 168 | 174 | 172 | 164 | 162  |
|  % Follow-up | 100% | 100% | 96% | 95% | 90% | 86% | 90% | 90% | 85% | 85%  |

TFU: Theoretical Follow-up = The number of implants that have entered the beginning of each interval window at the time of database lock.
EFU: Expected Follow-up = Theoretical Due - [Deaths + Components Removed/Revised + Consent Withdrawn]
AFU: Actual Follow-Up

A total of 10 subjects were withdrawn from this investigation. Three of 10 were investigational and 7 of 10 were control devices. Of the 3 investigational devices, 2 were revised and 1 died. Of the 7 control devices, 3 were revised, 3 died, and 1 withdrew consent. The deaths were for reasons unrelated to the device or procedure. Two (1 I and 1 C) of the 4 deaths occurred after study endpoint (24 month postoperative follow-up) had been obtained. Study endpoint data had already been obtained for the 1 subject who withdrew consent. There was no difference in the proportion of deaths (p=0.623) or study withdrawals (p=1.000) between the investigational and control treatments (see Table 10 below).

PMA P090002: FDA Summary of Safety and Effectiveness Data
27

{22}

Table 10: Comparison of Proportion of Deaths and Consent Withdrawals

|  Related Events | (I) AEs | (I) Subjects | (I) % | (C) AEs | (C) Subjects | (C) % | Exact p-value  |
| --- | --- | --- | --- | --- | --- | --- | --- |
|  Deaths | 1 | 194 | 0.52 | 3 | 196 | 1.53 | 0.623  |
|  Consent Withdrawals | 0 | 194 | 0.00 | 1 | 196 | 0.51 | 1.000  |

Figure 1 below is a dataset flowchart which shows all 390 subjects in the Safety Dataset, and the order in which they were excluded, from top to bottom, to obtain the Efficacy Dataset; revisions were retained regardless of exclusion criteria. The primary composite success/failure endpoint analysis was carried out on the Efficacy Dataset.

Figure 1: Subject Accounting Dataset Flowchart – All Enrolled Cohort

![img-1.jpeg](img-1.jpeg)

PMA P090002: FDA Summary of Safety and Effectiveness Data
page 23

{23}

# Subset Cohort of Subjects with S-ROM and Summit Porocoat Stems

The primary analysis was based on five femoral stem types; however, the applicant is only currently seeking marketing approval for the Summit Porocoat femoral stem (standard and high offset) and the S-ROM femoral stem as components for the Pinnacle® CoMplete® Acetabular Hip System.

At the time of database lock, complete 24 month postoperative data (study endpoint) was available on 86 COM & 86 MOM (control) (80% of COM subjects and 83% of MOM subjects) of the 226 subjects in the Subset Cohort of subjects who received the S-ROM or Summit Porocoat stems.

This is summarized in Table 11 below.

Table 11: Patient Accounting for Subset Cohort of S-ROM and Summit Porocoat Stems

|   | PreOp |   | 4 Week |   | 3 Month |   | 12 Month |   | 24 Month  |   |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
|   | COM | MOM | COM | MOM | COM | MOM | COM | MOM | COM | MOM  |
|  TFU | 114 | 112 | 114 | 112 | 114 | 112 | 114 | 112 | 114 | 112  |
|  Deaths (cumulative) | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 1  |
|  Component Removal (cumulative) | 0 | 0 | 1 | 1 | 1 | 1 | 1 | 1 | 2 | 2  |
|  EFU | 114 | 112 | 113 | 111 | 113 | 111 | 113 | 110 | 112 | 109  |
|  AFU | 114 | 112 | 106 | 104 | 100 | 101 | 101 | 99 | 90 | 91  |
|  % Follow-up | 100% | 100% | 94% | 94% | 88% | 91% | 89% | 90% | 80% | 83%  |
|  TFU: Theoretical Follow-up = The number of implants that have entered the beginning of each interval window at the time of database lock.
EFU: Expected Follow-up = Theoretical Due - [Deaths + Components Removed/Revised + Consent Withdrawn]
AFU: Actual Follow-Up  |   |   |   |   |   |   |   |   |   |   |

Figure 2 below is a dataset flowchart which shows all 226 S-ROM and Summit Porocoat stem subjects in the Safety Dataset, and the order in which they were excluded, from top to bottom, to obtain the Efficacy Dataset; revisions were retained regardless of exclusion criteria.

PMA P090002: FDA Summary of Safety and Effectiveness Data

{24}

![img-2.jpeg](img-2.jpeg)
Figure 2: Subject Accounting Dataset Flowchart; Subset Cohort (S-ROM, Summit Porocoat Stems)

## C. Study Population Demographics and Baseline Parameters

The demographics of the study population are typical for a total hip replacement study performed in the US. Clinical study data was collected on 390 hips implanted. There were 194 investigational hip implantations and 196 control hip implantations in the Protocol Defined Safety Dataset for the All Enrolled Cohort.

Comparisons were performed to determine whether the subject populations for the treatment groups were equivalent prior to study treatment. Comparisons were conducted using the Safety Dataset: means were compared with a t-test, and proportions were compared with Fisher’s Exact Test. Results of these analyses are provided in Table 12 below.

PMA P090002: FDA Summary of Safety and Effectiveness Data
page 25

{25}

Table 12: Baseline Demographics – All Enrolled Cohort

|  Demographic Element |  | COM N=194 | MOM N=196 | COM vs. MOM p-values  |
| --- | --- | --- | --- | --- |
|  Enrollment | Number of procedures | 194 | 196 | -  |
|   | Number of patients | 194 | 196 | -  |
|  Age in years | Mean Age | 58.9 | 59.1 | 0.792  |
|   |  Minimum Age | 24 | 25  |   |
|   |  Maximum Age | 75 | 75  |   |
|  Gender | Females | 83 (43%) | 91 (46%) | 0.478  |
|   |  Males | 111 (57%) | 105 (54%)  |   |
|  Body Mass Index [kg / m2] | Mean BMI | 29.5 | 29.8 | 0.598  |
|   |  Minimum BMI | 20.2 | 19.2  |   |
|   |  Maximum BMI | 49.2 | 48.8  |   |
|  Primary Diagnosis | Avascular Necrosis | 19 (10%) | 8 (4%) | 0.029  |
|   |  Developmental Dysplasia | 4 (2%) | 3 (2%) | 0.723  |
|   |  Epiphyseal Defect | 2 (1%) | 1 (1%) | 0.622  |
|   |  Osteoarthritis | 161 (83%) | 174 (89%) | 0.111  |
|   |  Post Traumatic Arthritis | 8 (4%) | 10 (5%) | 0.810  |
|  Harris Hip Score | Mean Pre-Op HH Score | 48.5 | 49.2 | 0.588  |
|   |  Minimum Pre-Op HH Score | 15 | 23  |   |
|   |  Maximum Pre-Op HH Score | 71 | 70  |   |
|  Harris Hip Pain Category (Range 0-44) | Mean Pre-op HH Pain | 13.1 | 13.5 | 0.491  |
|   |  Minimum Pre-op HH Pain | 0 | 0  |   |
|   |  Maximum Pre-op HH Pain | 20 | 20  |   |
|  Harris Hip Function Score (Range 0-33) | Mean Pre-op HH Function | 19.5 | 19.5 | 0.982  |
|   |  Minimum Pre-op HH Function | 2 | 2  |   |
|   |  Maximum Pre-op HH Function | 33 | 33  |   |
|  Harris Hip Activity Score (Range 0-14) | Mean Pre-op HH Activity | 8.1 | 8.4 | 0.110  |
|   |  Minimum Pre-op HH Activity | 0 | 2  |   |
|   |  Maximum Pre-op HH Activity | 14 | 14  |   |
|  Harris Hip Deformity Score (Range 0-4) | Mean Pre-op HH Deformity | 3.4 | 3.3 | 0.353  |
|   |  Minimum Pre-op HH Deformity | 0 | 0  |   |
|   |  Maximum Pre-op HH Deformity | 4 | 4  |   |
|  Harris Hip Range of Motion Score (Range 0-5) | Mean Pre-op HH ROM | 4.4 | 4.4 | 0.885  |
|   |  Minimum Pre-op HH ROM | 1 | 2  |   |
|   |  Maximum Pre-op HH ROM | 5 | 5  |   |

PMA P090002: FDA Summary of Safety and Effectiveness Data

{26}

The demographics of the subset cohort (subjects who received S-ROM and Summit Porocoat stems) study population are typical for a total hip replacement study performed in the US and consistent with the demographics of the All Enrolled Cohort.

Comparisons were performed to determine whether the subject populations for the treatment groups were equivalent prior to study treatment. Comparisons were conducted using the Safety Dataset: means were compared with a t-test, and proportions were compared with Fisher's Exact test.

Results of these analyses are provided in Table 13 below.

Table 13: Baseline Demographics - Subset Cohort (S-ROM and Summit Porocoat Stems)

|  Demographic Element |  | COM
N=114 | MOM
N=112 | COM vs. MOM
p-values  |
| --- | --- | --- | --- | --- |
|  Enrollment | Number of procedures | 114 | 112 | -  |
|   | Number of patients | 114 | 112 | -  |
|  Age in years | Mean Age | 58.5 | 58.9 | 0.744  |
|   |  Minimum Age | 24 | 25  |   |
|   |  Maximum Age | 75 | 75  |   |
|  Gender | Females | 55 (48%) | 53 (47%) | 0.895  |
|   |  Males | 59 (52%) | 59 (53%)  |   |
|  Body Mass Index
[kg / m2] | Mean BMI | 29.9 | 30.8 | 0.274  |
|   |  Minimum BMI | 20.7 | 19.8  |   |
|   |  Maximum BMI | 49.2 | 48.8  |   |
|  Primary Diagnosis | Avascular Necrosis | 12 (10.5%) | 7 (6%) | 0.338  |
|   |  Developmental Dysplasia | 3 (2.6%) | 2 (2%) | 1.000  |
|   |  Epiphyseal Defect | 2 (1.8%) | 0 (0%) | 0.498  |
|   |  Osteoarthritis | 93 (81.6%) | 98 (88%) | 0.271  |
|   |  Post Traumatic Arthritis | 4 (3.5%) | 5 (4%) | 0.747  |
|  Harris Hip Score | Mean Pre-Op HH Score | 47.4 | 47.5 | 0.950  |
|   |  Minimum Pre-Op HH Score | 15 | 23  |   |
|   |  Maximum Pre-Op HH Score | 69 | 66  |   |
|  Harris Hip Pain
Category
(Range 0-44) | Mean Pre-op HH Pain | 13.5 | 13.6 | 0.930  |
|   |  Minimum Pre-op HH Pain | 0 | 0  |   |
|   |  Maximum Pre-op HH Pain | 20 | 20  |   |
|  Harris Hip Function
Score
(Range 0-33) | Mean Pre-op HH Function | 18.7 | 18.6 | 0.948  |
|   |  Minimum Pre-op HH Function | 2 | 2  |   |
|   |  Maximum Pre-op HH Function | 30 | 33  |   |
|  Harris Hip Activity
Score
(Range 0-14) | Mean Pre-op HH Activity | 7.8 | 8.1 | 0.380  |
|   |  Minimum Pre-op HH Activity | 0 | 2  |   |
|   |  Maximum Pre-op HH Activity | 12 | 14  |   |
|  Harris Hip
Deformity Score
(Range 0-4) | Mean Pre-op HH Deformity | 3.1 | 2.8 | 0.327  |
|   |  Minimum Pre-op HH Deformity | 0 | 0  |   |
|   |  Maximum Pre-op HH Deformity | 4 | 4  |   |
|  Harris Hip Range of
Motion Score
(Range 0-5) | Mean Pre-op HH ROM | 4.3 | 4.4 | 0.654  |
|   |  Minimum Pre-op HH ROM | 1 | 2  |   |
|   |  Maximum Pre-op HH ROM | 5 | 5  |   |

PMA P090002: FDA Summary of Safety and Effectiveness Data

{27}

The demographics of the bilateral cohort (subjects who received a contra-lateral hip during the study period) study population are typical for a total hip replacement study performed in the US.

Comparisons were conducted and means were compared with a t-test, and proportions were compared with Fisher's Exact test. Results of these analyses are provided in Table 14 below.

Table 14: Baseline Demographics - Bilateral Cohort

|  Demographic Element |  | COM N=12 | MOM N=16 | COM vs. MOM p-values  |
| --- | --- | --- | --- | --- |
|  Enrollment | Number of procedures | 12 | 16 | -  |
|   | Number of patients | 12 | 16 | -  |
|  Age in years | Mean Age | 61.7 | 61.1 | 0.865  |
|   |  Minimum Age | 49 | 41  |   |
|   |  Maximum Age | 72 | 74  |   |
|  Gender | Females | 4 (33%) | 10 (63%) | 0.252  |
|   |  Males | 8 (67%) | 6 (37%)  |   |
|  Body Mass Index [kg / m2] | Mean BMI | 30.4 | 29.0 | 0.417  |
|   |  Minimum BMI | 23.2 | 23.4  |   |
|   |  Maximum BMI | 38.4 | 39.5  |   |
|  Primary Diagnosis | Avascular Necrosis | 4 (33%) | 0 (0%) | 0.024  |
|   |  Osteoarthritis | 8 (67%) | 16 (100%) | 0.024  |
|  Harris Hip Score | Mean Pre-Op HH Score | 47.1 | 48.7 | 0.704  |
|   |  Minimum Pre-Op HH Score | 34 | 28  |   |
|   |  Maximum Pre-Op HH Score | 62 | 66  |   |
|  Harris Hip Pain Category (Range 0-44) | Mean Pre-op HH Pain | 13.3 | 13.8 | 0.828  |
|   |  Minimum Pre-op HH Pain | 10 | 10  |   |
|   |  Maximum Pre-op HH Pain | 20 | 20  |   |
|  Harris Hip Function Score (Range 0-33) | Mean Pre-op HH Function | 17.9 | 18.6 | 0.719  |
|   |  Minimum Pre-op HH Function | 7 | 2  |   |
|   |  Maximum Pre-op HH Function | 24 | 30  |   |
|  Harris Hip Activity Score (Range 0-14) | Mean Pre-op HH Activity | 8.2 | 8.4 | 0.812  |
|   |  Minimum Pre-op HH Activity | 5 | 2  |   |
|   |  Maximum Pre-op HH Activity | 12 | 11  |   |
|  Harris Hip Deformity Score (Range 0-4) | Mean Pre-op HH Deformity | 3.3 | 3.5 | 0.766  |
|   |  Minimum Pre-op HH Deformity | 0 | 0  |   |
|   |  Maximum Pre-op HH Deformity | 4 | 4  |   |
|  Harris Hip Range of Motion Score (Range 0-5) | Mean Pre-op HH ROM | 4.3 | 4.4 | 0.698  |
|   |  Minimum Pre-op HH ROM | 3 | 3  |   |
|   |  Maximum Pre-op HH ROM | 5 | 5  |   |

## Component Distribution

The distribution of femoral stem and acetabular shell components of the system for each of the two treatment groups (investigational and control) is summarized below in Table 15 for subjects in the All Enrolled Cohort. The applicant is only seeking approval for two

PMA P090002: FDA Summary of Safety and Effectiveness Data

{28}

of the femoral stems actually studied as part of the clinical study (i.e., Summit Porocoat (standard and high offset) and S-ROM femoral stems).

Table 15: Device Component Distribution – All Enrolled Cohort

|   | COM Group |   | MOM Group  |   |   |
| --- | --- | --- | --- | --- | --- |
|   |   |  N | % | N | %  |
|  Head Size | 28mm | 11 | 6% | 13 | 7%  |
|   |  36mm | 183 | 94% | 183 | 93%  |
|  Femoral Stems | AML | 31 | 16% | 32 | 16%  |
|   |  Prodigy | 15 | 8% | 16 | 8%  |
|   |  Summit Porocoat | 67 | 35% | 65 | 33%  |
|   |  Standard Offset | 25 |  | 22 |   |
|   |  High Offset | 42 |  | 43 |   |
|   |  Summit Duofix | 34 | 18% | 36 | 18%  |
|   |  Standard Offset | 8 |  | 13 |   |
|   |  High Offset | 26 |  | 23 |   |
|   |  S-ROM | 47 | 24% | 47 | 24%  |
|  Acetabular Shells | 100 series | 107 | 55% | 116 | 59%  |
|   |  300 series | 9 | 5% | 7 | 4%  |
|   |  Multihole | 0 | 0% | 0 | 0%  |
|   |  Sector | 78 | 40% | 73 | 37%  |

The distribution of femoral stem and acetabular shell components of the system for each of the two treatment groups (investigational and control) is summarized below in Table 16 for subjects in the Subset Cohort (subjects who received S-ROM and Summit Porocoat stems).

Table 16: Device Component Distribution – Subset Cohort (S-ROM, Summit Porocoat Stems)

|   | COM |   | MOM  |   |   |
| --- | --- | --- | --- | --- | --- |
|   |   |  N=114 | % | N=112 | %  |
|  Head Size | 28mm | 7 | 6% | 6 | 5%  |
|   |  36mm | 107 | 94% | 106 | 95%  |
|  Femoral Stems | Summit Porocoat | 67 | 59% | 65 | 58%  |
|   |  Standard Offset | (25) | (22%) | (22) | (20%)  |
|   |  High Offset | (42) | (37%) | (43) | (38%)  |
|   | S-ROM | 47 | 41% | 47 | 42%  |
|  Acetabular Shells | 100 series | 57 | 50% | 64 | 57%  |
|   |  300 series | 9 | 8% | 7 | 6%  |
|   |  Sector | 48 | 42% | 41 | 37%  |

PMA P090002: FDA Summary of Safety and Effectiveness Data
page 29

{29}

The distribution of femoral stem and acetabular shell components of the system for each of the two treatment groups (investigational and control) is summarized below in Table 17 for subjects in the Bilateral Cohort (subjects who received a contra-lateral hip during the study period).

Table 17: Device Component Distribution – Bilateral Cohort

|   | COM |   | MOM  |   |   |
| --- | --- | --- | --- | --- | --- |
|   |   |  N=12 | % | N=16 | %  |
|  Head Size | 28mm | 1 | 8% | 1 | 6%  |
|   |  36mm | 11 | 92% | 15 | 94%  |
|  Femoral Stems | Summit Porocoat | 5 | 42% | 6 | 38%  |
|   |  Standard Offset | (0) | (0%) | (2) | (13%)  |
|   |  High Offset | (5) | (42%) | (4) | (25%)  |
|   |  Summit Duofix | 2 | 17% | 2 | 13%  |
|   |  S-ROM | 2 | 17% | 2 | 13%  |
|   |  AML | 3 | 25% | 5 | 31%  |
|  Acetabular Shells | Prodigy | 0 | 0% | 1 | 6%  |
|   |  100 series | 4 | 33% | 8 | 50%  |
|   |  300 series | 2 | 17% | 0 | 0%  |
|  Acetabular Shells | Sector | 6 | 50% | 8 | 50%  |

## D. Safety and Effectiveness Results

### 1. Safety Results

The analysis of safety was based on the following:

- Adverse Events
- A Kaplan-Meier Survivorship Analysis of revisions

The analysis of safety was based on all 390 enrolled subjects (194 investigational and 196 control cohorts) followed over the 24 month evaluation.

The key safety outcomes for this study are presented below in Tables 18 through 39.

**Adverse events that occurred in the PMA clinical study:**

The Safety Dataset was used to compare:

1) Revisions,
2) Adverse Events
3) Kaplan Meier Survivorship

### 1. Revisions

Revision was defined as a reoperation where any component (acetabular or femoral) was removed or replaced. There were a total of 2 revisions (1.0%) reported out of 194 procedures in the investigational cohort and 3 revisions

PMA P090002: FDA Summary of Safety and Effectiveness Data

{30}

(1.5%) reported out of 196 procedures in the control cohort. Table 18 provides a summary of the revision procedure, treatment group, age, gender, primary diagnosis, duration of implantation and reason for revision for each subject. None of the subjects in the Bilateral Cohort had a device revision. There appears to be no clinically meaningful difference in the rates of revision between the investigational and control cohorts.

Table 18: Revisions – All Enrolled Cohort

|  Procedure(s) | Treatment Group | Age / Gender | Primary Diagnosis | Duration of Implantation | Reason for Revision / Removal  |
| --- | --- | --- | --- | --- | --- |
|  Femoral ceramic head and metal insert removed and replaced | Investigational (COM) | 67/M | Osteoarthritis | 23.3 mo | Deep infection  |
|  Femoral ceramic head and metal insert removed and replaced | Investigational (COM) | 75/F | Osteoarthritis | 0.6 mo | Incision and Drainage procedure  |
|  Femoral metal head, insert, shell, and stem removed and replaced | Control (MOM) | 70/F | Osteoarthritis | 19.5 mo | Loose prosthesis and occult infection  |
|  Femoral metal head removed and replaced | Control (MOM) | 50/M | Avascular necrosis | 4.2 mo | Chronic dislocations  |
|  Femoral metal head was exchanged | Control (MOM) | 61/M | Osteoarthritis | 1 wk | Irrigation and debridement of a hematoma and evaluation of leg length stability intra-operatively  |

## 2. Adverse Events

Adverse events reported from the clinical study of 390 hip procedures are listed in Tables 19 through 36 below.

### a. Adverse Events by Subject

In Tables 19 through 27 below, every unique adverse event was reported once per subject, regardless of whether a single subject reported more than one instance of a particular adverse event. Fisher’s Exact Test was used to compare proportions across the two treatment groups.

PMA P090002: FDA Summary of Safety and Effectiveness Data
page 31

{31}

# 1. Intraoperative Complications

The most common intraoperative complication for the all enrolled cohort was femoral bone fracture, which was observed in 3.1% of all subjects (12/390). There was no difference in the proportions of observed intraoperative adverse events across treatment groups (see Table 19 below). Fisher’s Exact Test was used to compare proportions across the two treatment groups

Table 19: Comparison of Frequency of Intraoperative Adverse Events for the All Enrolled Cohort

|   | COM |   | MOM |   |   |
| --- | --- | --- | --- | --- | --- |
|  Adverse Events | AEs / Subjects (%) | 95% Confidence Interval | AEs / Subjects (%) | 95% Confidence Interval | p-value  |
|  Fracture of femur | 4 / 194 (2.1%) | 0.6 - 5.2 | 8 / 196 (4.1%) | 1.8 - 7.9 | 0.380  |
|  Seating acetabular prosthesis | 0 / 194 (0.0%) | - | 2 / 196 (1.0%) | 0.1 - 3.6 | 0.499  |
|  Seating femoral prosthesis | 1 / 194 (0.5%) | 0.0 - 2.8 | 1 / 196 (0.5%) | 0.0 - 2.8 | 1.000  |
|  Other complication | 2 / 194 (1.0%) | 0.1 - 3.7 | 3 / 196 (1.5%) | 0.3 - 4.4 | 1.000  |

Other intraoperative adverse events denoted as other complication above consisted of:

- COM: one (1) arterial bleed occurring during surgical approach, one (1) inadequate spinal anesthesia, and
- MOM: one (1) volatile blood pressure resolved with medical management, one (1) high spinal anesthesia level resulting in stoppage of case and repeat surgery without complication, and one (1) excessive blood loss and metal liner did not engage correctly resulting in a new shell and liner placement.

The intraoperative adverse events for the Subset Cohort (S-ROM, Summit Porocoat Stems) are provided below (Table 20). There were no clinically significant differences in the frequency of intraoperative adverse events between treatment groups.

PMA P090002: FDA Summary of Safety and Effectiveness Data
page 32

{32}

Table 20: Comparison of Frequency of Intraoperative Adverse Events Subset Cohort (S-ROM, Summit Porocoat Stems)

|   | COM |   | MOM  |   |
| --- | --- | --- | --- | --- |
|  Adverse Events | AEs / Subjects (%) | 95% Confidence Levels | AEs / Subjects (%) | 95% Confidence Levels  |
|  Fracture of femur | 2 / 114 (1.8%) | 0.2 - 6.2 | 6 / 112 (5.4%) | 2.0 - 11.3  |
|  Other complication | 2 / 114 (1.8%) | 0.2 - 6.7 | 3 / 112 (2.7%) | 0.6 - 7.6  |

The intraoperative adverse events for the Bilateral Cohort (subjects that received a contra-lateral hip during the study period) are provided below (Table 21).

Table 21: Comparison of Frequency of Intraoperative Adverse Events Bilateral Cohort

|   | COM |   | MOM  |   |
| --- | --- | --- | --- | --- |
|  Adverse Events | AEs / Subjects (%) | 95% Confidence Levels | AEs / Subjects (%) | 95% Confidence Levels  |
|  Fracture of femur | 0 / 12 (0.0%) | 0.0 - 0.0 | 1 / 16 (6.3%) | 0.2 - 30.2  |

2. Postoperative-Systemic Adverse Events

For both the investigational and control treatments the most commonly reported postoperative systemic complication was musculoskeletal. Frequently reported adverse events also included: cardiovascular, constitutional symptoms, gastrointestinal, respiratory, and dermatological.

There was no statistically or clinically meaningful difference in the proportion of postoperative systemic adverse events (see Table 22 below).

PMA P090002: FDA Summary of Safety and Effectiveness Data
page 33

{33}

Table 22: Comparison of Frequency of Postoperative Systemic Adverse Events – All Enrolled Cohort

|   | COM |   |   | MOM |   |   |   |
| --- | --- | --- | --- | --- | --- | --- | --- |
|  Adverse Events at the 24 month Endpoint | AEs / Subjects | % | 95% Confidence Interval | AEs / Subjects | % | 95% Confidence Interval | p-value*  |
|  Allergy | 0 / 194 | 0.0 | 0.0 - 0.0 | 1 / 196 | 0.5 | 0.0 - 2.8 | 1.000  |
|  Cancer | 3 / 194 | 1.5 | 0.3 - 4.5 | 3 / 196 | 1.5 | 0.3 - 4.4 | 1.000  |
|  Cardiovascular | 27 / 194 | 13.9 | 9.4 - 19.6 | 22 / 196 | 11.2 | 7.2 - 16.5 | 0.448  |
|  Central nervous system | 16 / 194 | 8.2 | 4.8 - 13.1 | 16 / 196 | 8.2 | 4.7 - 12.9 | 1.000  |
|  Constitutional symptom | 24 / 194 | 12.4 | 8.1 - 17.9 | 20 / 196 | 10.2 | 6.4 - 15.3 | 0.526  |
|  Dermatological | 20 / 194 | 10.3 | 6.4 - 15.5 | 19 / 196 | 9.7 | 5.9 - 14.7 | 0.867  |
|  Endocrine/metabolic | 5 / 194 | 2.6 | 0.8 - 5.9 | 5 / 196 | 2.6 | 0.8 - 5.9 | 1.000  |
|  Gastrointestinal | 21 / 194 | 10.8 | 6.8 - 16.1 | 21 / 196 | 10.7 | 6.8 - 15.9 | 1.000  |
|  Genitourinary | 17 / 194 | 8.8 | 5.2 - 13.7 | 20 / 196 | 10.2 | 6.4 - 15.3 | 0.730  |
|  Head, eyes, ears, nose and throat | 11 / 194 | 5.7 | 2.9 - 9.9 | 11 / 196 | 5.6 | 2.8 - 9.8 | 1.000  |
|  Hematological | 15 / 194 | 7.7 | 4.4 - 12.4 | 18 / 196 | 9.2 | 5.5 - 14.1 | 0.717  |
|  Infection | 1 / 194 | 0.5 | 0.0 - 2.8 | 0 / 196 | 0.0 | 0.0 - 0.0 | 0.497  |
|  Lymphatics | 2 / 194 | 1.0 | 0.1 - 3.7 | 0 / 196 | 0.0 | 0.0 - 0.0 | 0.247  |
|  Metabolic/laboratory | 2 / 194 | 1.0 | 0.1 - 3.7 | 2 / 196 | 1.0 | 0.1 - 3.6 | 1.000  |
|  Musculoskeletal | 107 / 194 | 55.2 | 47.9 - 62.3 | 101 / 196 | 51.5 | 44.3 - 58.7 | 0.479  |
|  Neurological | 1 / 194 | 0.5 | 0.0 - 2.8 | 0 / 196 | 0.0 | 0.0 - 0.0 | 0.497  |
|  Other - accident | 6 / 194 | 3.1 | 1.1 - 6.6 | 5 / 196 | 2.6 | 0.8 - 5.9 | 0.770  |
|  Other - edema | 4 / 194 | 2.1 | 0.6 - 5.2 | 2 / 196 | 1.0 | 0.1 - 3.6 | 0.448  |
|  Pain | 0 / 194 | 0.0 | 0.0 - 0.0 | 1 / 196 | 0.5 | 0.0 - 2.8 | 1.000  |
|  Peripheral nervous system | 7 / 194 | 3.6 | 1.5 - 7.3 | 8 / 196 | 4.1 | 1.8 - 7.9 | 1.000  |
|  Pulmonary embolism | 2 / 194 | 1.0 | 0.1 - 3.7 | 1 / 196 | 0.5 | 0.0 - 2.8 | 0.622  |
|  Respiratory system | 18 / 194 | 9.3 | 5.6 - 14.3 | 20 / 196 | 10.2 | 6.4 - 15.3 | 0.865  |
|  Thrombosis/thrombophlebitis | 1 / 194 | 0.5 | 0.0 - 2.8 | 1 / 196 | 0.5 | 0.0 - 2.8 | 1.000  |
|  Wound problem | 0 / 194 | 0.0 | 0.0 - 0.0 | 1 / 196 | 0.5 | 0.0 - 2.8 | 1.000  |

* $p$-values calculated using Fisher’s exact test for independent proportions (two-sided)

For both the investigational and control treatments the most commonly reported postoperative systemic complication was musculoskeletal. Frequently reported adverse events for the subset cohort included: cardiovascular and gastrointestinal.

There was no clinically meaningful difference in the frequency of postoperative systemic adverse events (see Table 23 below).

PMA P090002: FDA Summary of Safety and Effectiveness Data
page 34

{34}

Table 23: Comparison of Frequency of Postoperative Systemic Adverse Events – Subset Cohort (S-ROM, Summit Porocoat Stems)

|   | COM |   |   | MOM  |   |   |
| --- | --- | --- | --- | --- | --- | --- |
|  Adverse Events at the 24 month Endpoint | AEs / Subjects | % | 95% Confidence Levels | AEs / Subjects | % | 95% Confidence Levels  |
|  Cancer | 1 / 114 | 0.9 | 0.0 - 4.8 | 2 / 112 | 1.8 | 0.2 - 6.3  |
|  Cardiovascular | 16 / 114 | 14.0 | 8.2 - 21.8 | 13 / 112 | 11.6 | 6.3 - 19.0  |
|  Central nervous system | 11 / 114 | 9.6 | 4.9 - 16.6 | 8 / 112 | 7.1 | 3.1 - 13.6  |
|  Constitutional symptom | 17 / 114 | 14.9 | 8.9 - 22.8 | 11 / 112 | 9.8 | 5.0 - 16.9  |
|  Dermatological | 7 / 114 | 6.1 | 2.5 - 12.2 | 9 / 112 | 8.0 | 3.7 - 14.7  |
|  Endocrine/metabolic | 3 / 114 | 2.6 | 0.6 - 7.5 | 3 / 112 | 2.7 | 0.6 - 7.6  |
|  Gastrointestinal | 14 / 114 | 12.3 | 6.9 - 19.8 | 12 / 112 | 10.7 | 5.7 - 18.0  |
|  Genitourinary | 9 / 114 | 7.9 | 3.7 - 14.5 | 11 / 112 | 9.8 | 5.0 - 16.9  |
|  Head, eyes, ears, nose and throat | 4 / 114 | 3.5 | 1.0 - 8.7 | 5 / 112 | 4.5 | 1.5 - 10.1  |
|  Hematological | 10 / 114 | 8.8 | 4.3 - 15.5 | 8 / 112 | 7.1 | 3.1 - 13.6  |
|  Musculoskeletal | 56 / 114 | 49.1 | 39.6 - 58.7 | 56 / 112 | 50.0 | 40.4 - 59.6  |
|  Other - accident | 4 / 114 | 3.5 | 1.0 - 8.7 | 3 / 112 | 2.7 | 0.6 - 7.6  |
|  Other - edema | 3 / 114 | 2.6 | 0.6 - 7.5 | 2 / 112 | 1.8 | 0.2 - 6.3  |
|  Pain | 0 / 114 | 0.0 | 0.0 - 0.0 | 1 / 112 | 0.9 | 0.0 - 4.9  |
|  Peripheral nervous system | 5 / 114 | 4.4 | 1.4 - 9.9 | 4 / 112 | 3.6 | 1.0 - 8.9  |
|  Pulmonary embolism | 1 / 114 | 0.9 | 0.0 - 4.8 | 1 / 112 | 0.9 | 0.0 - 4.9  |
|  Respiratory system | 10 / 114 | 8.8 | 4.3 - 15.5 | 12 / 112 | 10.7 | 5.7 - 18.0  |
|  Thrombosis/thrombophlebitis | 0 / 114 | 0.0 | 0.0 - 0.0 | 1 / 112 | 0.9 | 0.0 - 4.9  |
|  Wound problem | 0 / 114 | 0.0 | 0.0 - 0.0 | 1 / 112 | 0.9 | 0.0 - 4.9  |

For both the investigational and control treatments the most commonly reported postoperative systemic complication was musculoskeletal. Frequently reported adverse events for the bilateral cohort included: cardiovascular, gastrointestinal, hematological and dermatological.

There was no clinically meaningful difference in the frequency of postoperative systemic adverse events (see Table 24 below).

PMA P090002: FDA Summary of Safety and Effectiveness Data
page 35

{35}

Table 24: Comparison of Frequency of Postoperative Systemic Adverse Events – Bilateral Cohort

|   | COM |   |   | MOM  |   |   |
| --- | --- | --- | --- | --- | --- | --- |
|  Adverse Events at the 24 month Endpoint | AEs / Subjects | % | 95% Confidence Levels | AEs / Subjects | % | 95% Confidence Levels  |
|  Cancer | 1 / 12 | 8.3 | 0.2 - 38.5 | 0 / 16 | 0.0 | 0.0 - 0.0  |
|  Cardiovascular | 4 / 12 | 33.3 | 9.9 - 65.1 | 6 / 16 | 37.5 | 15.2 - 64.6  |
|  Central nervous system | 2 / 12 | 16.7 | 2.1 - 48.4 | 1 / 16 | 6.3 | 0.2 - 30.2  |
|  Constitutional symptom | 1 / 12 | 8.3 | 0.2 - 38.5 | 2 / 16 | 12.5 | 1.6 - 38.4  |
|  Dermatological | 4 / 12 | 33.3 | 9.9 - 65.1 | 4 / 16 | 25.0 | 7.3 - 52.4  |
|  Endocrine/metabolic | 1 / 12 | 8.3 | 0.2 - 38.5 | 2 / 16 | 12.5 | 1.6 - 38.4  |
|  Gastrointestinal | 3 / 12 | 25.0 | 5.5 - 57.2 | 2 / 16 | 12.5 | 1.6 - 38.4  |
|  Genitourinary | 3 / 12 | 25.0 | 5.5 - 57.2 | 2 / 16 | 12.5 | 1.6 - 38.4  |
|  Head, eyes, ears, nose and throat | 0 / 12 | 0.0 | 0.0 - 0.0 | 2 / 16 | 12.5 | 1.6 - 38.4  |
|  Hematological | 2 / 12 | 16.7 | 2.1 - 48.4 | 5 / 16 | 31.3 | 11.0 - 58.7  |
|  Infection | 1 / 12 | 8.3 | 0.2 - 38.5 | 0 / 16 | 0.0 | 0.0 - 0.0  |
|  Metabolic/laboratory | 1 / 12 | 8.3 | 0.2 - 38.5 | 1 / 16 | 6.3 | 0.2 - 30.2  |
|  Musculoskeletal | 12 / 12 | 100 | 73.5 - 100.0 | 16 / 16 | 100 | 79.4 - 100.0  |
|  Other - accident | 1 / 12 | 8.3 | 0.2 - 38.5 | 0 / 16 | 0.0 | 0.0 - 0.0  |
|  Peripheral nervous system | 0 / 12 | 0.0 | 0.0 - 0.0 | 1 / 16 | 6.3 | 0.2 - 30.2  |
|  Pulmonary embolism | 2 / 12 | 16.7 | 2.1 - 48.4 | 0 / 16 | 0.0 | 0.0 - 0.0  |
|  Respiratory system | 4 / 12 | 33.3 | 9.9 - 65.1 | 2 / 16 | 12.5 | 1.6 - 38.4  |
|  Thrombosis/thrombophlebitis | 1 / 12 | 8.3 | 0.2 - 38.5 | 0 / 16 | 0.0 | 0.0 - 0.0  |

3. Postoperative Operative Site Adverse Events

The most commonly reported postoperative operative site complication for investigational and control subjects was trochanteric bursitis. Other complications included wound problems, dermatological, musculoskeletal, pain, and thigh pain.

There were no statistical differences in the proportions of postoperative operative site adverse events (see Table 25 below) for the All Enrolled Cohort, with the exception of ‘Other – Accident’, which showed a significantly higher proportion in the investigational COM group

PMA P090002: FDA Summary of Safety and Effectiveness Data

{36}

compared to the control MOM group (these consisted of hip pain, bruised hip, glass in foot, fall, and muscle strain).

Table 25: Comparison of Frequency of Postoperative Operative Site Adverse Events – All Enrolled Cohort

|   | COM |   |   | MOM |   |   |   |
| --- | --- | --- | --- | --- | --- | --- | --- |
|  Adverse Events at the 24m Endpoint | AEs / Subjects | % | 95% Confidence Interval | AEs / Subjects | % | 95% Confidence Interval | p-value*  |
|  Bone fracture | 2 / 194 | 1.0 | 0.1 - 3.7 | 4 / 196 | 2.0 | 0.6 - 5.1 | 0.685  |
|  Deep infection | 1 / 194 | 0.5 | 0.0 - 2.8 | 0 / 196 | 0.0 | 0.0 - 0.0 | 0.497  |
|  Dermatological | 13 / 194 | 6.7 | 3.6 - 11.2 | 7 / 196 | 3.6 | 1.5 - 7.2 | 0.176  |
|  Dislocation | 2 / 194 | 1.0 | 0.1 - 3.7 | 2 / 196 | 1.0 | 0.1 - 3.6 | 1.000  |
|  Hematoma | 3 / 194 | 1.5 | 0.3 - 4.5 | 2 / 196 | 1.0 | 0.1 - 3.6 | 0.684  |
|  Hematoma requiring drainage | 1 / 194 | 0.5 | 0.0 - 2.8 | 1 / 196 | 0.5 | 0.0 - 2.8 | 1.000  |
|  Infection | 0 / 194 | 0.0 | 0.0 - 0.0 | 1 / 196 | 0.5 | 0.0 - 2.8 | 1.000  |
|  Musculoskeletal | 8 / 194 | 4.1 | 1.8 - 8.0 | 7 / 196 | 3.6 | 1.5 - 7.2 | 0.799  |
|  Other - accident | 5 / 194 | 2.6 | 0.8 - 5.9 | 0 / 196 | 0.0 | 0.0 - 0.0 | 0.030  |
|  Other - edema | 0 / 194 | 0.0 | 0.0 - 0.0 | 4 / 196 | 2.0 | 0.6 - 5.1 | 0.123  |
|  Pain | 9 / 194 | 4.6 | 2.1 - 8.6 | 8 / 196 | 4.1 | 1.8 - 7.9 | 0.810  |
|  Pain: thigh | 8 / 194 | 4.1 | 1.8 - 8.0 | 4 / 196 | 2.0 | 0.6 - 5.1 | 0.258  |
|  Subluxation | 0 / 194 | 0.0 | 0.0 - 0.0 | 1 / 196 | 0.5 | 0.0 - 2.8 | 1.000  |
|  Trochanteric bursitis | 15 / 194 | 7.7 | 4.4 - 12.4 | 10 / 196 | 5.1 | 2.5 - 9.2 | 0.309  |
|  Wound problem | 12 / 194 | 6.2 | 3.2 - 10.6 | 10 / 196 | 5.1 | 2.5 - 9.2 | 0.667  |

* p-values calculated using Fisher’s exact test for independent proportions (two-sided)

The most commonly reported postoperative operative site complication for…

---

**Source:** [https://fda.innolitics.com/device/P090002](https://fda.innolitics.com/device/P090002)

**Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a PMA](https://innolitics.com/services/regulatory/), [a 510(k)](https://innolitics.com/services/510ks/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact).

**Cite:** Innolitics at https://innolitics.com