R3 Delta Ceramic Acetabular System PAS U.S.

Post-Approval Study of the R3 Biolox Delta Ceramic Acetabular System - US The R3 Ceramic
Acetabular System is indicated for use in skeletally mature patients requiring primary total
hip arthroplasty due to non-inflammatory arthritis (degenerative joint disease) such as
osteoarthritis, avascular necrosis, or traumatic arthritis. The expected timeline for the
study is a total of approximately 5 years: 6 months for site initiation, 12 months for
subject enrollment, 3 years until the last subject enrolled has reached the 3 year follow-up
interval.

Inclusion Criteria:

- Patient is 18-75 years old and he/she is skeletally mature

- Patient requires primary total hip arthroplasty due to non-inflammatory degenerative
joint disease (degenerative joint disease) such as osteoarthritis, avascular necrosis,
or traumatic arthritis.

- Patient has met an acceptable preoperative medical clearance and is free from or
treated for cardiac, pulmonary, hematological, etc., conditions that would pose
excessive operative risk

- Patient is willing and able to participate in required follow-up visits and to
complete study procedures and questionnaires

- Patient has consented to participating in the study by signing the IRB/EC approved
informed consent form

Exclusion Criteria:

- Patients with insufficient quantity or quality of bone support; metabolic bone
disease; osteoporosis

- Patients with neurological or muscular conditions that would place extreme load or
instability upon the hip joint

- Patients with active joint infections or chronic systemic infection

- Obese patients where obesity is defined as BMI > 40

- Skeletal immaturity

- Known allergy to implant materials