Journey BCS Knee Replacement System - Femoral Implant 의 리콜

Recall

RC-2014-RN-00004-1

Class II

2014-01-03

Australia

DHTGA

https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-00004-1

The femoral implant/tibial baseplate combination of the journey bcs knee system has been identified in the australian orthopaedic association’s national joint replacement registry (aoanjrr) as having a higher than expected revision rate when compared to all other primary total knee replacements.. the aoanjrr data indicates that journey bcs has a higher incidence of revisions due to patellofemoral pain, unspecified pain and instability. the most recent journey bcs knee system revision data published by the njrr include: - a revision rate of 1.59 (1.34, 1.88) revisions per 100 observed component years compared to 0.72 (0.70, 0.73) for other total knee replacements; and- a yearly cumulative percent revision of 7.0% (5.8, 8.4) at 5 years compared to 3.8% (3.7, 3.8) for other total knee replacements. smith & nephew is withdrawing the femoral implant component of the journey bcs knee system from the market.

Smith and Nephew is recommending that surgeons contact their patients who have been implanted with the Femoral Implant component as part of a primary knee replacement surgery and inform them of the current alert. Surgeons are advised to maintain standard follow-up protocols and actions for the care of their patients. Smith and Nephew do not recommend pre-emptive removal. Revision should only be undertaken when there are symptoms related to implant failure. JOURNEY BCS will no longer be available as a primary knee replacement system. The UHMWPE inserts of the JOURNEY BCS Knee System continues to be available for revision use. For more information, please see http://www.tga.gov.au/safety/alerts-device-journey-bcs-knee-replacement-system-140106.htm .