Zimmer Continuum Metal on Polyethylene (MoP) PostMarket Clinical Followup (PMCF) Study

The safety and performance of the Continuum Metal on Polyethylene Acetabular System will be
confirmed by the assessment of survival and outcome data. Assessments will include standard
scoring systems, radiographs and adverse event records. Data will be used to monitor pain,
mobility, and survivorship of the Continuum Metal on Polyethylene Acetabular system in
primary total hip arthroplasty. Metal ion (cobalt, chromium and titanium) and renal function
(BUN, Creatinine and GFR) levels will be analyzed for a subset of the enrolled study
subjects.

Inclusion Criteria

- Patient is 18 to 75 years of age, inclusive.

- Patient is skeletally mature.

- Patient qualifies for primary unilateral or bilateral (simultaneous or staged) total
hip arthroplasty (THA) based on physical exam and medical history including the
following:

- Avascular necrosis (AVN)

- Osteoarthritis

- Inflammatory arthritis (i.e., Rheumatoid arthritis)

- Post-traumatic arthritis

- Patient has no history of previous prosthetic replacement device of any type,
including surface replacement arthroplasty, endoprosthesis, etc. of the affected hip
joint(s).

- Patient has moderate, marked or disabling pain.

- Patient is willing and able to provide written informed consent.

- Patient is willing and able to cooperate in the required post-operative therapy.

- Patient is willing and able to complete scheduled follow-up evaluations as described
in the Informed Consent.

- Patient has participated in the Informed Consent process and has signed the IRB
approved informed consent.

Exclusion Criteria:

- The patient is:

- A prisoner

- Mentally incompetent or unable to understand what participation in the study
entails

- A known alcohol or drug abuser

- Anticipated to be non-compliant

- The patient has a neuromuscular disorder, vascular disorder or other conditions that
could contribute to prosthesis instability, prosthesis fixation failure or
complications in postoperative care.

- The patient has a neurologic condition in the ipsilateral or contralateral limb which
affects lower limb function.

- The patient has a diagnosed systemic disease that could affect his/her safety or the
study outcome.

- The patient is known to be pregnant.

- The patient is unwilling or unable to give consent or to comply with the follow-up
program.

- The patient has received an investigational drug or device within the previous 6
months.

- The patient has an active or latent infection in or about the affected hip joint or an
infection distant from the hip joint that may spread to the hip hematogenously.

- The patient has insufficient bone stock to fix the component. Insufficient bone stock
exists in the presence of metabolic bone disease (i.e., osteoporosis), cancer, and
radiation. Note: Dual Energy X-ray Absorptiometry (DEXA) may be used to assess the
presence of adequate bone stock.

- The patient has osteoradionecrosis in the affected hip joint.

- The patient has a known sensitivity or allergic reaction to one or more of the
implanted materials.

- The patient has known local bone tumors and/or cysts in the operative hip.

- The patient has a Body Mass Index (BMI) > 40.