Device Dossier

Global FX Porocoat Stem - Coated shoulder humeral stem prosthesis

Device Dossier for Global FX Porocoat Stem - Coated shoulder humeral stem prosthesis (Coated shoulder humeral stem prosthesis, Class III, sponsor DePuy…

Intended purpose

The Global FX Porocoat Stem is one component of total or hemi shoulder joint replacement. Total Shoulder or hemi-shoulder replacement is indicated for: 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. Rotator cuff tear arthropathy.

Functional description

The Global FX Porocoat Stem is made of CoCr and is coated with Porocoat (titanium sintered beads) intended to improve fixation and stability by promoting bone ingrowth. Global FX can be used for cemented or cementless applications. Global FX provides fixation within the proximal humerus and a site of attachment for a humeral head.

TGA Public Summary