Events

Rappel de S&N Birmingham Hip Resurfacing (BHR) Head

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
    18028
  • Date de mise en oeuvre de l'événement
    2015-02-05
  • 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
    Smith & nephew has updated the instructions for use of the bhr system to include an expansion of the warnings for certain population sub-groups, in line with available data sources including registry data., if a patient from the following population sub-groups is implanted with a bhr system, the patient is at greater risk of requiring a revision surgery earlier than expected:, * females, * males aged 65 or greater, * patients requiring an implant head size < 48mm, patients who experience symptoms including pseudotumors, tissue masses, fluid collections, enlarges bursae, pain and swelling local buildup of excessive metal particles or metal hypersensitivity, may require revision surgery, with attendant risks and the potential for impaired function.
  • Action
    Instructions for use to be updated

Device

S&N Birmingham Hip Resurfacing (BHR) Head
  • Modèle / numéro de série
    Model: 74121138, 74123140, 74121142, 74123144, 74121146, 74123148, 74121150, 74123152, 74121154, 74123156, 74121158, 74123160, 74123162, Affected: All lots
  • Manufacturer
    Smith & Nephew Orthopaedics Ltd

Manufacturer

Smith & Nephew Orthopaedics Ltd