Events

Rappel de Journey BCS Knee Replacement System - Femoral Implant

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par Smith & Nephew Surgical Pty Ltd.

Qu'est-ce que c'est?

Une correction ou un retrait opéré par un fabricant afin de répondre à un problème causé par un dispositif médical. Les rappels surviennent lorsqu'un dispositif médical est défectueux, lorsqu'il pourrait poser un risque pour la santé, ou les deux à la fois.

En savoir plus sur les données ici
  • Type d'événement
    Recall
  • ID de l'événement
    RC-2014-RN-00004-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2014-01-03
  • Pays de l'événement
    Australia
  • Source de l'événement
    DHTGA
  • URL de la source de l'événement
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-00004-1
  • Notes / Alertes
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Australia.
  • Notes supplémentaires dans les données
  • Cause
    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.
  • Action
    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 .

Device

Journey BCS Knee Replacement System - Femoral Implant

Manufacturer

Smith & Nephew Surgical Pty Ltd