Alerte Ou Avis De Sécurité sur VKS, RT-Plus and TC-Plus femoral and tibial knee components

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 Plus Orthopaedics/Smith & Nephew Orthopaedics Ltd.

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
    Extension of recall of implants which may have incorrect alloy composition. as a result of a manufacturing error, some knee implant components have been made from an alloy of incorrect composition. in november 2007, the manufacturer recalled some affected products and provided the mhra with a list of uk affected products (see appendix (in pdf only) - rows in grey). the mhra issued mda/2007/092 relating to this recall, on 4 december 2007. the manufacturer extended the recall in december 2007 (see appendix (in pdf only) for full list of uk affected products). 520 affected products have been distributed to uk hospitals since june 2007. the clinical implications for patients implanted with affected products are currently being assessed. the manufacturer’s initial risk assessment is that there is no indication of any health risk to patients as a result of the higher iron content in these devices. the manufacturer is, however, carrying out further tests in order to fully assess the situation. the mhra will issue further advice on patient management when this assessment has been completed.
  • Action
    Do not implant affected products (lot numbers listed in Appendix). Quarantine all affected products and return them to the manufacturer. Report revisions or adverse incidents related to affected products to the MHRA.


  • Modèle / numéro de série
  • Description du dispositif
    Total knee replacement implants. VKS, RT-Plus and TC-Plus femoral and tibial knee components manufactured by Plus Orthopaedics/Smith & Nephew Orthopaedics Ltd (specific lot numbers).
  • Manufacturer