Device Dossier

R3 HA Coated Hemispherical Acetabular Shell - Acetabular shell

Device Dossier for R3 HA Coated Hemispherical Acetabular Shell - Acetabular shell (Acetabular shell, Class III, sponsor Smith & Nephew). ARTG record,…

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 outer portion of a two-piece cementless acetabulum prosthesis intended to be used with a liner which serves as an articulating surface. The acetabular shell is inserted into a pre-pared acetabulum with an inserter and impacted into place. It may be further affixed with bone screws.

TGA Public Summary