Rappel de BIRMINGHAM HIP Resurfacing (BHR) System BHR Resurfacing Head

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
  • ID de l'événement
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
  • Pays de l'événement
  • Source de l'événement
  • URL de la source de l'événement
  • 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 (s&n;) has conducted an analysis of recent national joint registry of england and wales data. the data indicate that 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 .S&n; is informing customers that: - the use of bhr in female patients is to be contraindicated;- bhr femoral head components sized 46mm in diameter and smaller, and their corresponding acetabular cup sizes, are no longer to be used and are to be returned to s&n; and- patients requiring a 48mm femoral head size are at a moderately elevated risk of revision and should not be considered as candidates for bhr implantation.
  • Action
    Surgeons are advised that 48mm heads should only be used in the specific circumstance of intra-operative downsizing from a pre-operatively templated 50mm to a measured 48mm at the time of surgery. Surgeons are recommended to maintain their routine follow-up protocol for patients who have undergone hip resurfacing arthroplasty. Patients who experience symptoms including limited mobility, pain, swelling, enlarged bursae, pseudotumors, tissue masses, fluid collections, or local build-up of excessive metal particles or metal hypersensitivity, may require revision surgery, with attendant risks and the potential for impaired function. The need for any additional follow-up, including the necessity for diagnostic imaging and blood tests, should be determined on a case-by-case basis following a detailed assessment of the patients’ clinical circumstances. This action has beem closed-out on 31/08/2016.


  • Modèle / numéro de série
    BIRMINGHAM HIP Resurfacing (BHR) System BHR Resurfacing HeadCatalogue Numbers: 74121138, 74123140, 74121142, 74123144, 74121146BHR Acetabular CupCatalogue Numbers: 74120144, 74120146, 74122146, 74122148, 74120148, 74120150, 74122150, 74122152, 74120152, 74120154BHR Dysplasia CupCatalogue Numbers: 74120246, 74122248, 74120250, 74122252, 74120254ARTG numbers: 120078 & 124099
  • Manufacturer