Device Dossier

Trabecular Metal Acetabular Revision Shell - Acetabular shell

Device Dossier for Trabecular Metal Acetabular Revision Shell - Acetabular shell (Acetabular shell, Class III, sponsor Zimmer Biomet). ARTG record,…

Intended purpose

These devices are intended for hip joint arthroplasty. Indications include: • Painful, disabling joint disease of the hip resulting from: degenerative arthritis, rheumatoid arthritis, or late-stage avascular necrosis. • Previous unsuccessful femoral head replacement, cup arthroplasty, or other procedure. • Clinical management problem where arthrodesis or alternative reconstruction techniques are less likely to achieve satisfactory results. • Where bone stock is of poor quality or is inadequate for other reconstructive techniques as indicated by deficiencies of the acetabulum.

Functional description

The Trabecular Metal Revision Acetabular Shells have an elliptical geometry and are manufactured from Trabecular Metal with a titanium alloy face ring and dome screw holes to allow for additional fixation when required. Fixation to the host bone is cementless and accomplished through press-fit, while the device is designed to be used with a compatible liner using a cemented application.

TGA Public Summary