Events

Rappel de S&N Birmingham Hip Modular Head, 36mm to 62mm

Selon New Zealand Medicines and Medical Devices Safety Authority, ce/cet/cette rappel concerne un dispositif en/au/aux/à New Zealand qui a été fabriqué par Smith & Nephew Orthopaedics 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
    18345
  • Date de mise en oeuvre de l'événement
    2015-04-16
  • Pays de l'événement
    New Zealand
  • Source de l'événement
    NZMMDSA
  • URL de la source de l'événement
    https://medsafe.govt.nz/hot/Recalls/RecallSearch.asp
  • Notes / Alertes
    Data from New Zealand is current through July 2018. All of the data comes from the New Zealand Medicines and Medical Devices Safety Authority, 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 New Zealand.
  • Notes supplémentaires dans les données
    Recalling Organisation: Smith & Nephew Surgical Ltd, Unit A 36 Hillside road, Wairau Valley, AUCKLAND 0760
  • Cause
    In october 2012, smith & nephew issued a hazard alert informing surgeons and hospitals that the birmingham hip™ modular head had 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 late 2014, smith & nephew became aware of new information relating to the performance of bhmh. also, recent registry and clinical data has showed a decline in the performance of the bhmh., based on the analysis of this information, smith & nephew considers that patients implanted with the bhmh device may be at greater risk of revision surgery.
  • Action
    Manufacturer to issue advice regarding use

Device

S&N Birmingham Hip Modular Head, 36mm to 62mm
  • Modèle / numéro de série
    Model: Catalogue Numbers: 74222138, 74222140, 74222142, 74222144, 74222146, 74222148, 74222150, 74222152, 74222154, 74222156, 74222158, 74222160, 74222162, Affected: All lots
  • Manufacturer
    Smith & Nephew Orthopaedics Ltd

Manufacturer

Smith & Nephew Orthopaedics Ltd