Rappel de Birmingham Hip Modular Head (BHMH) (component of MoM total hip replacement systems)

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;) is issuing an update to the oct 2012 hazard alert after analysis of new information identified that patients implanted with the bhmh may be at greater risk of revision surgery. the new revision risk estimate for the bhmh is: -10.6% (95% ci: 9.55, 11.65) at six years follow-up from the national joint registry for england, wales and northern ireland (data accessed in january 2015).. - 11.7% (95% cl: 9.7, 14.0) at ten years of follow-up from aoa njrr (report published in october 2014 based on data collected to end december 2013).Also, a small clinical study undertaken in the uk with patients implanted with sleeved bhmh and uncemented synergy stems indicates that there is a potential increased risk of fretting corrosion and accelerated release of metal debris at the taper junctions of the modular taper sleeve interface with the stem and with the head.
  • Action
    S&N; recommends that physicians maintain their routine follow-up protocol for patients who have undergone total hip arthroplasty. Patients may present with pain and limited mobility, potentially leading to a greater risk of revision surgery. Patients who experience symptoms including 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. For more information, please see http://www.tga.gov.au/alert/birmingham-hip-modular-head-used-hip-replacements This action has been closed-out on 31/08/2016.


  • Modèle / numéro de série
    Birmingham Hip Modular Head (BHMH) (component of MoM total hip replacement systems)BHMH 38MM~62MM (Sleeved) Catalogue Numbers: 74222138 to 7422216212/14 Modular Taper Sleeve Catalogue Numbers: 74222100, 74222200, 74222300, 74222400All batches/lotsARTG Number: 124100
  • Manufacturer