Global Unite Standard Stem - Coated shoulder humeral stem prosthesis

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Available from:

Johnson & Johnson Medical Pty Ltd t/a DePuy Synthes

Class:

Class III

Manufactured by:

Depuy (Ireland) Loughbeg Ringaskiddy, COUNTY CORK Ireland

Therapeutic area:

39702 - Coated shoulder humeral stem prosthesis

Therapeutic indications:

The Global Unite Stem is manufactured from titanium and coated in Porocoat. The Global Unite Stem affixes to the Global Unite Body. The Global Unite Stem is one component of the Global Unite Reverse Shoulder System and intended for cemented or uncemented 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

Authorization status:

A

Authorization date:

2014-02-15