Events

Rappel de Birmingham Hip Product Range BHR Resurfacing Head BHR Acetabular CupCHR Dysplasia Cup BIRMINGHAM HIP Modular Head Sleeved 38MM~62MM 12/14 Modular Taper Sleeve BIRMINGHAM HIP Modular Head Monoblock 38MM~58MM

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 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-2016-RN-00436-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2016-05-03
  • 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-2016-RN-00436-1
  • 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 is issuing an update to a medical device hazard alert issued in 2015 to provide surgeons and hospitals with updated information on the birmingham hip resurfacing (‘bhr’) product range and the birmingham hip modular head (bhmh) system. this update contains a current summary of the information concerning the revision rates of various products in the bhr and bhmh systems (including the monoblock version of the bhmh system).
  • Action
    The sponsor is recommending that physicians maintain their routine follow-up protocol for patients who have undergone THA. Patients who experience symptoms including pain, swelling, enlarged bursae, pseudo-tumours, 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 been closed-out on 24/05/2017.

Device

Birmingham Hip Product Range BHR Resurfacing Head BHR Acetabular CupCHR Dysplasia Cup BIRMINGHAM ...
  • Modèle / numéro de série
    Birmingham Hip Product RangeBHR Resurfacing HeadBHR Acetabular CupCHR Dysplasia CupBIRMINGHAM HIP Modular Head Sleeved 38MM~62MM 12/14 Modular Taper SleeveBIRMINGHAM HIP Modular Head Monoblock 38MM~58MMMultiple Catalogue Numbers affectedAll batches affectedARTG Numbers:120078, 124099, 124100
  • Manufacturer
    Smith & Nephew Pty Ltd

Manufacturer

Smith & Nephew Pty Ltd