Device Dossier
EcoFit 2M cup cemented TiN - Acetabular shell
Device Dossier for EcoFit 2M cup cemented TiN - Acetabular shell (Acetabular shell, Class III, sponsor Life Healthcare). ARTG record, intended purpose,…
- GMDN category: Acetabular shell
Intended purpose
A cemented acetabular cup used in combination with a dual mobility 2M implacross E head or Ecofit 2M head, and a regular femoral head as part of a total hip replacement procedure. Total hip replacement with the EcoFit 2M hip system applies to the following indications: - Non- inflammatory degenerative joint disease including osteoarthritis and avascular necrosis, - Post-traumatic osteoarthritis, - Fractures, - Rheumatoid arthritis, - Acquired or congenital dysplastic disorders of the hip with increased risk of dislocation and instability, - After complications such as dislocation revision surgery is required, leaving the existing stem in place and reducing the risk of dislocation, - Revision.
Functional description
The EcoFit 2M cemented cup TiN is made of implavit CoCrMo-casting alloy with Titanium nitride coating. To enhance the cement mantle the outer surface of the cemented cup has grooves and notches. The cup is part of a tripolar system and is designed to articulate with an EcoFit 2M or 2M implacross E head which in turn articulates with a femoral head.