Global Unite Standard Stem - Coated shoulder humeral stem prosthesis

국가: 오스트레일리아

언어: 영어

출처: Department of Health (Therapeutic Goods Administration)

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공공 평가 보고서 공공 평가 보고서 (PAR)
01-12-2017

제공처:

Johnson & Johnson Medical Pty Ltd t/a DePuy Synthes

수업:

Class III

Manufactured by:

Depuy (Ireland) Loughbeg Ringaskiddy, COUNTY CORK Ireland

치료 영역:

39702 - Coated shoulder humeral stem prosthesis

치료 징후:

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

승인 상태:

A

승인 날짜:

2014-02-15

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