Device Dossier

BIRMINGHAM HIP Resurfacing HAP Coated Acetabular Cup - Metallic acetabulum prosthesis

Device Dossier for BIRMINGHAM HIP Resurfacing HAP Coated Acetabular Cup - Metallic acetabulum prosthesis (Metallic acetabulum prosthesis, Class III,…

Intended purpose

The BIRMINGHAM HIP Resurfacing (BHR) Acetabular Cup is a component of the BHR system. The BHR system is intended for use in patients requiring primary hip resurfacing arthroplasty due to: • Non-inflammatory arthritis (degenerative joint disease) such as osteoarthritis, traumatic arthritis, avascular necrosis, or dysplasia/DDH, or • Inflammatory arthritis such as rheumatoid arthritis.

Functional description

A sterile porous press-fit cobalt-chrome alloy (Co-Cr) hemispherical acetabular cup used in metal on metal articulation with a cemented femoral head. The outer surface of the cup has a single layer of integrally-cast Co-Cr beads on the outer surface that are coated with hydroxyapatite (HA). The acetabular cup is supplied with a disposable polyethylene impactor cap wired to the cup with disposable introducer cables. After sequential reaming of the acetabulum, the cup is impacted into place.

TGA Public Summary