Device Dossier

Dual Mobility PE Liner - Non-constrained polyethylene acetabular liner

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

Intended purpose

This device is intended for permanent prosthetic replacement of the acetabular component of the hip joint, during first-line or revision total hip arthroplasty.Target population: Adult population, older than 70. Patients who are candidates for total hip arthroplasty with a very high risk of displacement, and patients who are candidates for revisionarthroplasty in cases of repeated displacement or with a high risk of displacement. Total hip replacement is intended for use in patients with a very painful joint and/or persistent disability after an observation period of several weeks following the failure of a well-conducted medical treatment. STATED CLINICAL PERFORMANCES Functional recovery, Joint function restored, Pain relief, Life-span of implants 10 years INDICATIONS: when used with the SYMBOL CUP DM HA cups • Destruction of the hip joint resulting from degenerative, post-traumatic lesion. • Fracture or avascular necrosis of the femoral head When used with the SYMBOL CUP DMR HA and the SYMBOL CUP DM CEM cups: • Destruction of the hip joint resulting from degenerative, post-traumatic lesion. • Hip prosthesis revision.

Functional description

Dual mobility PE Liners are manufactured in moulded form UHMWPE and can accommodate 22.2 or 28mm diameter femoral heads. A compatible femoral head is inserted into the liner. After verifying that there’s good mobility and good head retention in the liner, the assembly is inserted into the cup. The device provides the articulating surface for the prosthesis, and is used to articulate with the femoral head in a hip arthroplasty.

TGA Public Summary