Adaptive Acetabular Liner PE VIT? - Anti-Dislocation - Non-constrained polyethylene acetabular liner

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Available from:

Orthotech Pty Ltd

Class:

Class III

Manufactured by:

Societa Azionaria Materiale Ospedaliero - SAMO spa Via G Matteotti 37 Cadriano di Granarolo Emilia, Bologna, 40057 Italy

Therapeutic area:

43168 - Non-constrained polyethylene acetabular liner

Therapeutic indications:

The truncoconical UHMWPE + VitE anti-dislocation liner with a 20? covering shoulder & internal ?22-40mm hemispherical seat to match that of the selected femoral head. It couples with the acetabular cup via an 18? tapered junction, utilising a triple locking mechanism: Morse taper to limit micromovements, potential backside wear, fatigue & breakage/dissociation risks; daisy lock to resist potential liner rotation to the acetabular cup housing; snap-on locking to resist pull-out forces. The Adaptive Acetabular Liner PE-VITAE Anti-dislocation component is of the SAMO Adaptive Acetabular Integrated System and is indicated for use in total hip arthroplasty for reduction or relief of pain and/or improved hip function in primary or revision cases in patients. It is indicated for the following: - Extensive primary and secondary destruction of the joint to the extent that the functional efficiency of the locomotive apparatus is reduced; - Severe pathological condition affecting the articulation caused by degenerative and rheumatoid arthritis; - Joint fracture or bone necrosis; - Post-surgical conditions after previous operations with or without consequent use of a prosthesis.

Authorization status:

A

Authorization date:

2017-11-07