Device Dossier
Trabecular Metal™ Revision Acetabular Shell - Acetabulum prosthesis
Device Dossier for Trabecular Metal™ Revision Acetabular Shell - Acetabulum prosthesis (Acetabulum prosthesis, Class III, sponsor Zimmer Biomet). ARTG…
- GMDN category: Acetabulum prosthesis
Intended purpose
Trabecular Metal Revision Acetabular Shells are indicated for: • Painful, disabling joint disease of the hip resulting from: degenerative arthritis, rheumatoid arthritis or late stage avascular necrosis. • Revision of 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 screwholes. They are intended for use with a cemented Replacement UHMWPE liner.