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…
- GMDN category: Acetabulum prosthesis
- Sponsor: Stryker
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).