Ceramic-on-Ceramic (COC) 36mm Acetabular Bearing Insert Post Approval Study-New Subjects (COC36mmPAS)

Up to 10 (up to 5 original IDE + 5 new sites)

A prospective, non-controlled, non-randomized, multicenter study. Subjects will be seen for a
clinic visit pre-operatively at the time of consent, (-90 days to surgery) and then at
post-operatively at 6 weeks (1-92 days), 1 year (275-455 days), 2 years (640-820 days) and 3
years (1005-1185days), 4 years (1370-1550 days), and a minimum of 5 years (1825- 2919 days).

Data collected will include: Pre-operatively subject history and demographics; Operative and
device details; and Post-operatively Harris HIp scores, Subject Hip Outcomes, and Adverse
Events.

In order to optimize mid-term follow-up compliance, site personnel are permitted to contact
the study subject in the 3 and 4 year intervals by phone (in place of a clinic visit) to
assess the current status of the hip.

Inclusion Criteria:

- Males and females between 21 - 75 at the time of surgery.

- Individuals, who in the opinion of the investigator, are suitable candidates for
primary total hip replacement using the devices specified in this protocol.

- Individuals with non-inflammatory degenerative joint disease (NIDJD) or any of its
composite diagnoses of osteoarthritis, avascular necrosis, and posttraumatic
arthritis.

- Individuals who are willing and able to provide informed patient consent for
participation in the study;

- Individuals who are willing and able to return for follow-up as specified by the study
protocol; and

- Individuals who are willing and able to complete the Subject Hip Outcomes
questionnaire as specified by the study protocol.

Exclusion Criteria:

- Skeletally immature patients (tibial and femoral epiphyses not closed)

- Evidence of active infections that may spread to other areas of the body
(e.g.,osteomyelitis, pyogenic infection of the hip joint, overt infection, urinary
tract infection, etc.)

- The presence of any known neoplastic (tumor-causing) or metastatic (spread of
cancerous cells) disease

- Significant neurologic or musculoskeletal disorders or diseases that may adversely
affect gait, weight bearing or postoperative recovery (e.g., muscular dystrophy,
multiple sclerosis)

- Presence of highly communicable disease(s) that may limit follow-up (e.g.,
immuno-compromised conditions, hepatitis, active tuberculosis, etc.)

- Any condition that may interfere with postoperative recovery (e.g., Paget's disease,
Charcot's disease)

- Inadequate bone stock to support the device (e.g., severe osteopenia orosteoporosis)

- Poor skin coverage around the hip joint

- Use in patients with known allergies to the implant materials

- Marked atrophy (muscle and/or tissue loss) or deformity in the upper femur such as a
birth defect affecting the leg bones.

- Inflammatory degenerative joint disease (like rheumatoid arthritis)

- Subject has participated in an IDE/IND clinical investigation, other than the
COC28/COC36 IDE or PAS for their contralateral hip, with an investigational product in
the last three months.

- Subject is currently involved in a personal injury litigation, medical-legal or
worker's compensation claims.

- Subject is a known drug or alcohol abuser or has a psychological disorder that could
affect their ability to comply with protocol procedures and/or subject-completed
questionnaires.

- The Subject is a woman who is pregnant or lactating.

- The Subject has a medical condition with less than 2 years of life expectancy.