Device Dossier

MDM X3 INSERT - Acetabulum prosthesis

Device Dossier for MDM X3 INSERT - Acetabulum prosthesis (Acetabulum prosthesis, Class III, sponsor Stryker). ARTG record, intended purpose, GMDN…

Intended purpose

The MDM X3 Insert is coupled with the MDM Liner which is used as part of the replacement of the acetabulum component that is indicated for a total hip arthroplasty for non-inflammatory degenerative joint disease including osteo and rheumatoid arthritis and avascular necrosis; correction of functional deformity; revision procedures where other treatments have failed and treatment of non-union, femoral neck and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques; dislocation risks. The insert is for cementless use.

Functional description

This Acetabular Insert is the inner portion of an artificial three-piece acetabulum prosthesis that is sterile and made of X3 polyethylene (highly cross-linked UHWMPE), provides the second articulating surface for the acetabulum prosthesis. The Acetabular Insert articulates both with the Acetabular Liner and an artificial Femoral Head as part of a Total Hip Arthroplasty (THA).

TGA Public Summary