Device Dossier

PE Dual Mobility Liner - Non-constrained polyethylene acetabular liner

Device Dossier for PE Dual Mobility Liner - Non-constrained polyethylene acetabular liner (Non-constrained polyethylene acetabular liner, Class III,…

Intended purpose

The Device is a dual mobility liner for use in total hip arthroplasty. Hemi and total hip arthroplasties are indicated for the treatment of symptomatic pain and/or functional problems of the hip in patients whose skeleton is mature and only when pain killer medicamentation and correctly followed conservative treatment have failed. For the patient, his anatomy and the structure of his articulation will need to be adapted to receive the selected implant(s). Indications for total or partial hip arthroplasty are: - Degenerative non inflammatory hip disease (coxarthrosis, arthritis of the hip). - Inflammatory hip disease (rheumatoid arthritis, post traumatic arthritis). - Metabolic hip disease (chondrocalcinosis). - Post Traumatic degenerative arthritis. - Avascular necrosis. - Congenital dysplasia of the hip. - Functional repair of a recent trauma (fracture, dislocation) - Revision of a failed conservative surgery, osteosynthesis, partial or total arthroplasty. - Tumoral surgery when affecting the hip joint.

Functional description

PE Dual Mobility Liner are manufactured from polyethylene with an internal geometry designed for a large coverage of the femoral head and a retentive force of the head in the liner > 100kg. A minimum outer diameter of 40mm provides joint stability and limits the risk of liner/cup dislocation. The offset between the rotary center of the head and the rotary centre of the liner enables automatic recentring of the liner in the cup in monopodal stance.

TGA Public Summary