Events

Rappel de BIRMINGHAM HIP RESURFACING SYSTEM (BHR) - ACETABULAR CUPS

Selon Health Canada (via FOI), ce/cet/cette rappel concerne un dispositif en/au/aux/à Canada qui a été fabriqué par SMITH & NEPHEW INC..

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
    22587
  • Classe de risque de l'événement
    II
  • Date de mise en oeuvre de l'événement
    2015-06-05
  • Pays de l'événement
    Canada
  • Source de l'événement
    HC
  • Notes / Alertes
    Canadian data is current through March 2018. All of the data comes from Health Canada, 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 Canada.
  • Notes supplémentaires dans les données
  • Cause
    As part of its post market surveillance (pms) and post-marketing clinical follow-up processes smith & nephew has conducted an analysis of recent national joint registry of england and wales (njrew) data (the largest arthroplasty registry cohort of bhr patients). a health hazard evaluation (hhe) was conducted to review this analysis. the data indicate that the bhr system continues to perform well in the male population requiring femoral head components 50mm in diameter and larger. however the revision rates associated with the female gender and smaller femoral head sizes regardless of gender perform less well and exceed the current revision rate benchmark established by the uk national institute for health and care excellence (nice).

Device

BIRMINGHAM HIP RESURFACING SYSTEM (BHR) - ACETABULAR CUPS
  • Modèle / numéro de série
    Model Catalog: 74120144 (Lot serial: ALL); Model Catalog: 74121146 (Lot serial: ALL); Model Catalog: 74123144 (Lot serial: ALL); Model Catalog: 74121142 (Lot serial: ALL); Model Catalog: 74123140 (Lot serial: ALL); Model Catalog: 74121138 (Lot serial: ALL); Model Catalog: 74120254 (Lot serial: ALL); Model Catalog: 74122252 (Lot serial: ALL); Model Catalog: 74120250 (Lot serial: ALL); Model Catalog: 74122248 (Lot serial: ALL); Model Catalog: 74120146 (Lot serial: ALL); Model Catalog: 74122146 (Lot serial: ALL); Model Catalog: 74122148 (Lot serial: ALL); Model Catalog: 74120148 (Lot serial: ALL); Model Catalog: 74120150 (Lot serial: ALL); Model Catalog: 74122150 (Lot serial: ALL); Model Catalog: 74122152 (Lot serial: ALL); Model Catalog: 74120246 (Lot serial: ALL); Model Catalog: 74120154 (Lot serial: ALL); Model Catalog: 74120152 (Lot serial: ALL)
  • Description du dispositif
    BIRMINGHAM HIP RESURFACING SYSTEM (BHR) - ACETABULAR CUPS
  • Manufacturer
    SMITH & NEPHEW INC.

Manufacturer

SMITH & NEPHEW INC.