Device Dossier

EXETER CONTEMPORARY Flanged Cup - Prosthesis, internal, joint, hip, acetabular component

Device Dossier for EXETER CONTEMPORARY Flanged Cup - Prosthesis, internal, joint, hip, acetabular component (Acetabulum prosthesis, Class III, sponsor…

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 and hemi hip arthroplasty include: 1. noninflammatory degenerative joint disease including osteoarthritis and avascular necrosis; 2. rheumatoid arthritis (except the OSTEOLOCK HA Acetabular Cup and Peri-Apatite coated prostheses); 3. correction of functional deformity; 4. revision procedures where other treatments or devices have failed; and, 5. treatment of nonunion, femoral neck and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques.

Functional description

This Ultra High Molecular Weight Polyethylene (UHMWPE) acetabular insert is designed to be used with out a shell and is available with varying inner diameters to help accomodate the mating femoral head. Four polymethylmethacrylate (PMMA) cement spacers are attached to the cup to maintain a minimum thickness of cement mantle. The cup has a flat non-hooded face.

TGA Public Summary