Events

Rappel de Birmingham Hip Resurfacing (BHR) 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-2015-RN-00080-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2015-02-03
  • 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-2015-RN-00080-1
  • 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
    Smith & nephew has updated the instructions for use of the birmingham hip resurfacing (bhr) system to include an expansion of the warnings for certain population sub-groups, in line with available data sources including registry data. the ifu has been updated to note that: 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: (a) females, (b) males aged 65 or greater, (c) patients requiring an implant head size =48m, (d) patients who have a diagnosis of avascular necrosis; and (e) patients who have congenital dysplasia. patients who experience symptoms including pseudotumors, tissue masses, fluid collections, enlarged 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
    Smith & Nephew is contacting all the implanting surgeons of Birmingham Hip Resurfacing (BHR) system to inform them of the changes to the IFU. Smith & Nephew is recommending the surgeons to use the BIRMINGHAM HIP Resurfacing System only after considering the warning statement and indications for use in the updated IFU attached. Smith & Nephew is further recommending to continue to apply standard practices for patient follow-up care. Smith & Nephew is forwarding the IFU's to two hospitals that have stock on hand. This action has been closed-out on 31/08/2016.

Device

Birmingham Hip Resurfacing (BHR) System
  • Modèle / numéro de série
    Birmingham Hip Resurfacing (BHR) SystemMultiple catalogue numbersAll batchesARTG numbers: 120078 & 124099
  • Manufacturer
    Smith & Nephew Surgical Pty Ltd

Manufacturer

Smith & Nephew Surgical Pty Ltd