Device Dossier

Trident II Tritanium Solidback Acetabular Shell - Acetabular shell

Device Dossier for Trident II Tritanium Solidback Acetabular Shell - Acetabular shell (Acetabular shell, Class III, sponsor Stryker). ARTG record,…

Intended purpose

Intended for cementless fixation into a prepared acetabulum for either primary or revision Total Hip Arthroplasty. Indications for Use - Painful, disabling joint disease of the hip resulting from: degenerative arthritis, rheumatoid arthritis, post-traumatic arthritis or late stage avascular necrosis. - Revision of previous unsuccessful femoral head replacement, cup arthroplasty or other procedure. - Clinical management problems where arthrodesis or alternative reconstructive 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. When used with MDM Liners - Treatment of nonunion, femoral neck and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques. - Dislocation risks When used with Constrained Liner - The Trident Constrained Acetabular Insert is indicated for use in primary and revision patients at high risk of hip dislocation due to a history of prior dislocation, bone loss, joint or soft tissue laxity, neuromuscular disease, or intraoperative instability.

Functional description

A metal acetabular shell intended to connect with a TRIDENT acetabular bearing liner. The shells are intended for cementless fixation within the prepared acetabulum. The Hex Dome Hole Plug is packaged with the Solidback Shell and is an optional device made available to help seal the TRIDENT II Shell. Material: Ti 6Al-4V

TGA Public Summary