SMR Stemless Reverse Liner CoCrMo - Metallic reverse shoulder prosthesis cup

国: オーストラリア

言語: 英語

ソース: Department of Health (Therapeutic Goods Administration)

即購入

ダウンロード 公開評価報告書 (PAR)
07-11-2017

から入手可能:

Lima Orthopaedics Australia Pty Ltd

クラス:

Class III

製:

Limacorporate Spa Via Nazionale 52, San Daniele del Friuli, Frazione Villanova Udine, 33038 Italy

治療領域:

60514 - Metallic reverse shoulder prosthesis cup

適応症:

The Reverse Liner is made of CoCrMo and is used uncemented. The humeral construct consists of the stemless core and the reverse liner. To fit the liner it is necessary to choose the relevant trial reverse liner and insert it into the Stemless Core, aligning the groove accordingly. The trial is then reduced to verify the shoulder tensioning and address any laxity by replacing with the next liner size. The trial liner is then replaced with the reverse liner implant of the corresponding size. The SMR Stemless System is intended for partial or total, primary or revision shoulder joint replacement. Revision surgery is intended only where the Stemless Core is stable, well positioned and osseointegrated and it is intended only as revision of a failed SMR Stemless primary implant with an anatomic implant or a conversion from anatomic to reverse or CTA or from reverse to CTA or in case of a failed SMR Resurfacing implant. Other revisions of the humeral prosthesis part should be treated with traditional shoulder prostheses. The SMR Stemless Anatomic System is indicated for partial or total, primary or revision shoulder joint replacement in patients suffering from disability due to: ? non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis; ? inflammatory degenerative joint disease such as rheumatoid arthritis; ? revision of a failed SMR Stemless primary implant with conversion from anatomic to reverse; ? revision of a failed SMR Resurfacing implant; ? cuff tear arthropathy (CTA Heads only). The SMR Stemless Reverse System is indicated for primary or revision total shoulder replacement in a grossly rotator cuff deficient joint with severe arthropathy (disabled shoulder). The patient's joint must be anatomically and structurally suited to receive the selected implants and a functional deltoid muscle is necessary to use the device.

認証ステータス:

A

承認日:

2015-04-02

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