Device Dossier
PEXEL-E DM Liner - Non-constrained polyethylene acetabular liner
Device Dossier for PEXEL-E DM Liner - Non-constrained polyethylene acetabular liner (Non-constrained polyethylene acetabular liner, Class III, sponsor…
- GMDN category: Non-constrained polyethylene acetabular liner
Intended purpose
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 medication 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). The recommended indications for dual mobility cup and liner are: − Primary arthroplasties for patients at high risk of dislocation (severe neurological affliction, neu-ropsychiatric disorders, addictions and severe neuromuscular deficiencies), − Revision arthroplasties in cases of recurrent dislocations for patients at high risk of articular in-stability.
Functional description
PEXEL-E DM Liner is a dual mobility liner manufactured from highly crosslinked UHMWPE with vitamin E. The internal geometry, in particular the value of the constraint diameter, designed for a large coverage of the femoral head and a retentive force of the head in the liner > 100 kg. There is an offset between the centre of rotation of the head and the centre of rotation of the liner to enable automatic recentring of the liner in the cup.