Alerte Ou Avis De Sécurité sur DePuy Ultima TPS femoral stem used in combination with Ultima metal-on-metal articulation

Selon Medicines and Healthcare products Regulatory Agency, ce/cet/cette alerte ou avis de sécurité concerne un dispositif en/au/aux/à United Kingdom qui a été fabriqué par manufacturer #17429.

Qu'est-ce que c'est?

Les avis de sécurité sont des communications que les fabricants de dispositifs médicaux ou leurs représentants font parvenir en particulier aux travailleurs du secteur médical, mais aussi aux utilisateurs de ces dispositifs. Les avis de sécurité concernent les actions entreprises quant aux dispositifs présents sur le marché et peuvent inclure des rappels et des alertes.

En savoir plus sur les données ici
  • Type d'événement
    Safety alert / Field Safety Notice
  • ID de l'événement
  • Numéro de l'événement
  • Date
  • Pays de l'événement
  • Source de l'événement
  • URL de la source de l'événement
  • Notes / Alertes
    Data from the United Kingdom is current through April 2019. All of the data comes from the Medicines and Healthcare products Regulatory Agency, 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 the United Kingdom.
  • Notes supplémentaires dans les données
  • Cause
    Unexplained groin pain. the need for early revision due to periprosthetic soft tissue necrosis. the ultima tps femoral stem and ultima metal-on-metal articulation (femoral head plus metal acetabular cup) is a total hip replacement system that has been on the market in the uk since 1997. the ultima tps femoral stem is still available but the ultima metal-on-metal femoral head and acetabular cup were discontinued in 2005. up to april 2007, one uk study has reported 43 revisions (from a cohort of 637 hips) associated with extensive periprosthetic soft tissue necrosis. some also involved late dislocation or periprosthetic fracture. the revisions were required one to seven years after implantation. there have been no other confirmed reports. when these stems were explanted, extensive corrosion was observed on the surface of many of them within the area of the cement mantle. this level of corrosion of cemented polished cobalt chromium molybdenum stems has not previously been reported in the orthopaedic literature and the explanation for it is unclear. depuy has already communicated this information to uk hospitals that implanted these devices. a copy of their letter, including recommendations for imaging and patient management, is in the appendix.
  • Action
    Refer patients with this implant combination who present with unexplained groin pain for MRI scan. This is in line with the parameters recommended by DePuy (see recommendations for patient management under ‘Action’ in the appendix). Patients with abnormal signs should be considered for an early revision. Report all revisions of metal-on-metal articulations where corrosion and/or periprosthetic soft tissue reaction are observed to the implant manufacturer and the MHRA.


  • Modèle / numéro de série
  • Description du dispositif
    Total hip replacement: DePuy Ultima TPS femoral stem used in combination with Ultima metal-on-metal articulation. DePuy Ultima TPS femoral stem used in combination with Ultima metal-on-metal articulation. These components were only sold in combination in the UK, France and Italy.
  • Manufacturer