METAL SHELL, CEM.LESS ‘DeltaLox’ SCREW FIX., TiNb-COAT (Acetabular shell component used for hip replacement) 의 리콜

Recall

RC-2015-RN-00210-1

Class II

2015-03-17

Australia

DHTGA

https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-00210-1

The ‘deltalox’ acetabular shells have a higher than expected revision rate as reported by the australian orthopaedics association national joint replacement registry. an analysis published alongside the 2014 annual report of the aoanjrr indicates that the yearly cumulative percent revision is 5.9% at 1 year and 9.0% at 2 years. in comparison, the cumulative percent revision for other total conventional hip replacements is 1.6% at 1 year and 2.1% at 2 years. the main reasons for revision have been dislocation, loosening/lysis and fracture.

Implanting surgeons are advised to schedule annual clinical and radiological examinations for patients who have been implanted with this device, in accordance with routine patient post-arthroplasty care. RQSolutions Medical Devices Distribution Support Pty Ltd is also undertaking a recall of un-implanted stock. RQSolutions has ceased supply of ‘DeltaLox’ acetabular implants and is cancelling them from the Australian Register of Therapeutic goods (ARTG). For additional information please see https://www.tga.gov.au/alert/deltalox-acetabular-shells-used-hip-implants . This action has been closed-out on 09/08/2016.