Events

Rappel de Journey BCS Knee System - Femoral Components Journey BCS CoCr Femoral Component Journey BCS Oxinium Femoral Component Journey BCS Tibial InsertAll Batch/Lot Numbers

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 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-2018-RN-00859-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2018-07-02
  • 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-2018-RN-00859-1
  • 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
    In january 2014, smith & nephew issued a hazard alert for the journey bcs knee system (tga ref: rc-2014-rn-00004-1) which informed surgeons of the higher than expected revision rate identified by the aoanjrr and advised of the withdrawal of the journey bcs femoral component for primary surgery from the australian market.Smith & nephew is now issuing an update following an analysis of the national joint registry of england, wales & northern ireland (njrewni) & australian orthopaedic association national joint replacement registry (aoanjrr) data on the 1st generation journey bcs knee system.The journey bcs tibial insert remains available for use but should only be used for polyethylene exchange revision of first generation journey bcs total knee constructs where the femoral component and tibial baseplate are well fixed.
  • Action
    Surgeons should maintain their routine follow-up protocol for patients who have undergone total knee arthroplasty. Signs and symptoms to consider for potential revisions are no different from those that might be reported by any patient having undergone primary total knee arthroplasty. The need for revision should be determined on a case-by-case basis following a detailed assessment of each patient’s clinical circumstances. Smith & Nephew is not recommending pro-active revision surgeries for patients implanted with this device.

Device

Journey BCS Knee System - Femoral Components Journey BCS CoCr Femoral Component Journey BCS Oxini...
  • Modèle / numéro de série
    Journey BCS Knee System - Femoral ComponentsJourney BCS CoCr Femoral ComponentJourney BCS Oxinium Femoral ComponentJourney BCS Tibial InsertAll Batch/Lot NumbersMultiple Catalogue NumbersARTG Number: 278110(Smith & Nephew Pty Ltd - JOURNEY BCS Articular Insert - Prosthesis, internal, joint, knee, tibial component)
  • Manufacturer
    Smith & Nephew Pty Ltd

Manufacturer

Smith & Nephew Pty Ltd