Cementless Columbus Knee System Multiple components 의 리콜

Recall

RC-2013-RN-00637-1

Class II

2013-06-27

Australia

DHTGA

https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2013-RN-00637-1

B. braun is withdrawing the cementless version of the columbus knee system from the australian register of therapeutic goods (artg) and is issuing a hazard alert to implanting surgeons. the decision to withdraw the cementless version of the columbus knee system was based on an analysis of data collected by the australian national joint replacement registry (njrr), which revealed that the cementless columbus knee system had a higher than acceptable revision rate.The cumulative revision rate (including all 33 revisions) for the cementless columbus knee system is 2.7% (95% ci: 1.6, 4.6) at one year from the time of implantation, 6.9% (95% ci: 4.8, 9.7) at three years, and 7.5% (95% ci: 5.3, 10.5) at five years, respectively, which is higher compared to all other total knee replacements with a cumulative revision rate of 1.0% (95% ci: 1.0, 1.0) at one year from the time of implantation, 2.7% (95% ci: 2.7, 2.8) at three years, and 3.6% (95% ci: 3.6, 3.7) at five years.

Given the nature of the problem, orthopaedic surgeons are advised that there is no need to contact patients who have received an cementless Columbus Knee System additionally in addition to regular examinations; however, it is recommended that implanting surgeons conduct regular clinical and radiological examinations on those patients, in accordance with routine patient post-arthroplasty care, and advise them of this issue at that stage. For more details, please see http://www.tga.gov.au/safety/alerts-device-columbus-knee-system-130709.htm