Device Dossier

BI-MENTUM Dual Mobility System Cemented Acetabular Cup - Acetabular shell

Device Dossier for BI-MENTUM Dual Mobility System Cemented Acetabular Cup - Acetabular shell (Acetabular shell, Class III, sponsor DePuy Synthes). ARTG…

Intended purpose

Acetabular cups combining a “Cemented Cup” and a “PE Liner” are intended for the treatment of the following indications: osteoarthritis of the hip, fractures of the femoral neck, periacetabular metastatic disease, patients with a risk of instability (neurological, tumour, revision, dearthrodesis, cognitive issues, etc.), that could compromise the primary stability, particularly recommended in cases of osteoporotic bone, osteonecrosis, dysplasia, can be used for rehabilitation after severe Paprosky type IIIA and IIIB acetabular destruction, by cementing the cup in a fixed acetabular cage, can be used alone (without a fixed acetabular cage), when other acetabular cups are not appropriate, surgical revision (including recurrent dislocation and loosening) if the bone reconstruction allows, Paprosky type IIIA and IIIB bone defects.

Functional description

The BI-MENTUM Cemented Cup is a dual mobility acetabular cup manufactured from stainless steel. The exterior is unpolished and presents a macro-geometry to increase the surface in contact with the cement. The inner surface is mirror polished. It is packaged with a disposable cup impactor that holds the implant in position while the cement hardens. It is to be used in combination with an acetabular femoral head and a PE liner.

TGA Public Summary