Vaios Total Shoulder Replacement System 의 리콜

Recall

RC-2015-RN-00976-1

Class II

2015-10-15

Australia

DHTGA

https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-00976-1

The tga has cancelled the vaios total shoulder replacement system, sponsored by orthotech, from the australian register of therapeutic goods (artg) due to a higher than expected revision rate. information published by the australian orthopaedic association’s national joint replacement registry (aoanjrr) indicated that the vaios total shoulder replacement system had a revision rate at two years of 17.6%. the comparable revision rate for all other total conventional shoulder implants was 5.5% at two years. the main reasons for revision were instability/dislocation, rotator cuff insufficiency and loosening/lysis.

Orthotech are advising clinicians to consider contacting patients who have been implanted with these devices to inform them of this issue. Implanting surgeons are advised to maintain their routine follow-up protocol for patients who have undergone shoulder arthroplasty. The need for any additional follow-up or revision surgery should be determined on a case-by-case basis following a detailed assessment of the patient’s clinical circumstances. This action has been closed-out on 29/08/2016.