Events

Alerte Ou Avis De Sécurité sur Kinemax Plus Revision TS Tibial Inserts

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
    MDA/2008/066
  • Numéro de l'événement
    CON025818
  • Date
    2008-09-18
  • Pays de l'événement
    United Kingdom
  • Source de l'événement
    MHRA
  • URL de la source de l'événement
    https://webarchive.nationalarchives.gov.uk/20141206095400/http://www.mhra.gov.uk/PrintPreview/PublicationSP/CON025818
  • 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
    Risk of loosening, excessive wear and fracture of knee replacement components, due to a manufacturing defect. patients with revision knee replacements may have received a tibial insert with a manufacturing defect. the affected devices have an incorrectly machined stabiliser post recess, which prevents the tibial insert from fitting correctly over the stabiliser post. the manufacturer has contacted all uk users to recall the affected devices (see the manufacturer’s field safety notice in appendix). 112 affected devices were distributed in the uk. as a result of the recall, 73 unused devices have been returned to the manufacturer. the remaining 39 devices may have been implanted in patients. patients who have received these implants are at risk of loosening, excessive wear and/or fracture of components. these could be caused by any of the following reasons: the gap between components was not detected during assembly excessive force was required to seat the insert with the base plate a smaller stabiliser post from a smaller sized insert was used to complete the surgery.
  • Action
    Do not implant affected devices Identify any affected stock that has not been implanted, and return to manufacturer Follow the patient management recommendations in this alert. Do not implant affected devices Identify any affected stock that has not been implanted, and return it to the manufacturer Identify which patients have been implanted with affected devices Ensure that affected patients, including those without symptoms, are followed up in accordance with usual standards of care for revision knee replacement patients (the manufacturer recommends follow-up at 6 weeks, 6 months, 12 months, and annually thereafter) Advise patients implanted with affected devices to report any increasing pain, or any symptoms of knee instability such as clicking Consider the need for revision for symptomatic patients.

Device

Kinemax Plus Revision TS Tibial Inserts
  • Modèle / numéro de série
  • Description du dispositif
    Total knee replacement implants: Stryker Orthopaedics Kinemax Plus Revision TS Tibial Inserts (specific product and lot codes – see Appendix in pdf only).
  • Manufacturer
    manufacturer #17429

Manufacturer

manufacturer #17429