Device Dossier
MPact DM Cementless Acetabular Shell - Acetabular shell
Device Dossier for MPact DM Cementless Acetabular Shell - Acetabular shell (Acetabular shell, Class III, sponsor Medacta). ARTG record, intended purpose,…
- GMDN category: Acetabular shell
Intended purpose
Device intended for use in total hip arthroplasty to provide increased patient mobility and reduced pain by replacing the damaged hip joint, in primary or revision surgery. Total hip arthroplasty is indicated in the following cases: • Severely painful and/or disabled joint as a result of arthrosis, traumatic arthritis, rheumatoid polyarthritis or congenital hip dysplasia. • Avascular necrosis of the femoral head. • Acute fracture of the femoral head. • Acute fracture of the proximal femur (not for neck preserving stems). • Failure of previous hip surgery: - Conservative hip surgery. - Internal fixation. - Arthrodesis. - Partial or total hip arthroplasty (not for neck preserving stems). - Hip resurfacing replacement.
Functional description
The MPACT Double Mobility (MPACT DM) is a hemispherical press-fit acetabular shell which can be coupled with double mobility liners. The MPACT Double Mobility Acetabular Shell is a component of a total hip joint prosthesis that is used to replace the acetabulum. The component is an outer shell, made of high nitrogen stainless steel; a double mobility liner of polymer is inserted in it. The design of the component is unconstrained. It is used without bone cement.