Device Dossier

EXETER X3 RIMFIT CUPS - Polyethylene acetabulum prosthesis

Device Dossier for EXETER X3 RIMFIT CUPS - Polyethylene acetabulum prosthesis (Polyethylene acetabulum prosthesis, Class III, sponsor Stryker). ARTG…

Intended purpose

A component of a total hip joint prosthesis that is used to replace or repair the acetabulum. The indications for use for total hip arthroplasty include: • 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 inadequate for other reconstructive techniques, such as cementless fixation, as indicated by deficiencies of the acetabulum.

Functional description

A sterile implantable acetabular cup made of X3 polyethylene (highly cross-linked UHMWPE) with an outer flange and 4 factory assembled polymethylmethacrylate (PMMA) cement spacers which provide a minimum of 2mm or 3mm cement mantle upon cemented implantation. The cup has a stainless steel X-ray wire to help identify the cup position on an X-ray. Available with varying inner diameters to help accommodate the mating Femoral Head.

TGA Public Summary