Device Dossier

R3 XLPE Acetabular Liners - Non-constrained polyethylene acetabular liner

Device Dossier for R3 XLPE Acetabular Liners - Non-constrained polyethylene acetabular liner (Non-constrained polyethylene acetabular liner, Class III,…

Intended purpose

Hip components are indicated for individuals undergoing primary and revision surgery where other treatments or devices have failed in rehabilitating hips damaged as a result of degenerative joint disease or any of its composite diagnoses of osteoarthritis, avascular necrosis, and traumatic arthritis. Hip components are also indicated for inflammatory degenerative joint disease including rheumatoid arthritis, congenital dysplasia, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques, and fracture-dislocation of the hip.

Functional description

The sterile, cross-linked polyethylene liner is placed into an acetabular shell and seated with an impactor and mallet. It provides coverage to allow adequate joint function.

TGA Public Summary