Global Unite Humeral Head - Humeral head prosthesis

Land: Australien

Sprog: engelsk

Kilde: Department of Health (Therapeutic Goods Administration)

Tilgængelig fra:

Johnson & Johnson Medical Pty Ltd t/a DePuy Synthes

Klasse:

Class III

Fremstillet af:

Depuy (Ireland) Loughbeg Ringaskiddy, COUNTY CORK Ireland

Terapeutisk område:

48088 - Humeral head prosthesis

Terapeutiske indikationer:

The Global Unite Humeral Head is manufactured from CoCr and affixes to the the stem of the Global Unite proximal body and articulates with the humeral cup. Eccentric Heads accomodate patients with off-centre proximal humerus. The Global Unite Humeral Head is one component of the Global Unite Reverse Shoulder System and intended for total shoulder or hemi-shoulder replacement in treatment of the following: 1. A severely painful and/or disabled joint resulting from osteoarthritis, traumatic arthritis or rheumatoid arthritis 2. Fracture-dislocations of the proximal humerus where the articular surface is severely comminuted, separated from its blood supply or where the surgeon?s experience indicates that alternative methods of treatment are unsatisfactory 3. Other difficult clinical problems where shoulder arthrodesis or resection arthroplasty are not acceptable (e.g. revision of a failed primary component) Hemi-shoulder replacement is also indicated for: 1. Ununited humeral head fractures 2. Avascular necrosis of the humeral head 3. Deformity and/or limited motion

Autorisation status:

A

Autorisation dato:

2014-04-08