Events

Rappel de Birmingham Hip Modular Head (Used as part of a Total Conventional Hip Replacement system)

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-2012-RN-00988-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2012-10-02
  • 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-2012-RN-00988-1
  • 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 birmingham hiptm modular head (bhmh) as part of a total conventional hip replacement system has been identified in the australian national joint replacement registry (njrr) and the national joint registry of england and wales (njrew) as having a higher than expected revision rate when compared to all other total conventional hip replacements. in addition, most of the revisions that are occurring later (after the third year) are linked to metal sensitivity and infection.
  • Action
    Smith & Nephew is advising implanting/treating surgeons on how to manage patients implanted with the Birmingham Hip Modular Heads. For more information, please see http://www.tga.gov.au/safety/alerts-device-hip-bhmh-121030.htm

Device

Birmingham Hip Modular Head (Used as part of a Total Conventional Hip Replacement system)
  • Modèle / numéro de série
    Birmingham Hip Modular Head (Used as part of a Total Conventional Hip Replacement system)Part Numbers : 121238 – 121258, 121338 – 121558, 74121238 – 74121558 & 74222138 – 74222162 All Batches ARTG Number: 124100
  • Manufacturer
    Smith & Nephew Surgical Pty Ltd

Manufacturer

Smith & Nephew Surgical Pty Ltd