Device Dossier
Freeliner PEXEL-E (Vit.) Liner - Non-constrained polyethylene acetabular liner
Device Dossier for Freeliner PEXEL-E (Vit.) Liner - Non-constrained polyethylene acetabular liner (Non-constrained polyethylene acetabular liner, Class…
- GMDN category: Non-constrained polyethylene acetabular liner
Intended purpose
Device 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 treatments have failed. Indications include: - 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
Freeliner PEXEL-E Liners are manufactured from highly crosslinked UHMWPE irradiated in a two step process; a first irradiation exposure at 75kgy gamma ray of the Vitamin-E blended material before machining, and a final exposure at 25kgy after packaging under opaque and vacuumed conditioning. PEXEL-E liners are available in inner diameters 32mm, 36mm and 40mm with neutral wall only.