Device Dossier
2M Cups Double Mobility System Mobile Liners (UHMWPE) - Non-constrained polyethylene acetabular liner
Device Dossier for 2M Cups Double Mobility System Mobile Liners (UHMWPE) - Non-constrained polyethylene acetabular liner (Non-constrained polyethylene…
- GMDN category: Non-constrained polyethylene acetabular liner
Intended purpose
The 2M System is indicated for use in total hip arthroplasty for reduction or relief of pain and/or improved hip function in skeletally mature patients with the following conditions: • non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis and hip dysplasia; • rheumatoid arthritis; • posttraumatic arthritis; • correction of functional deformity; • fractures, dislocation of the hip and unsuccessful cup arthroplasty; • revisions in cases of good remaining bone stock.
Functional description
The liner functions as part of a double mobility system. The liner articulates with an acetabular cup and femoral head as part of a total hip arthroplasty. The liner has an inner clearance of 0.3 mm with respect to the femoral head. The outer clearance has been increased to 0.6 mm to avoid locking of the outer joint due to the interposition of fibrous tissue. The centre of the inner head is cranialized with respect to the centre of the liner (1,5 mm), to permit the self-centring of the system.