Global Unite Standard Stem - Coated shoulder humeral stem prosthesis

国家: 澳大利亚

语言: 英文

来源: Department of Health (Therapeutic Goods Administration)

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公众评估报告 公众评估报告 (PAR)
01-12-2017

可用日期:

Johnson & Johnson Medical Pty Ltd t/a DePuy Synthes

类:

Class III

厂商:

Depuy (Ireland) Loughbeg Ringaskiddy, COUNTY CORK Ireland

治疗领域:

39702 - Coated shoulder humeral stem prosthesis

疗效迹象:

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

授权状态:

A

授权日期:

2014-02-15

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