Alerte Ou Avis De Sécurité sur Unicondylar sled knee prosthesis

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 Waldemar Link GmbH & Company.KG.

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
  • Numéro de l'événement
    MDA/2014/018
  • Date
    2014-05-28
  • Date de publication de l'événement
    2014-12-17
  • Pays de l'événement
  • Source de l'événement
    MHRA
  • 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
    Risk of early wear of the ultra high molecular weight polyethylene (UHMWPE) plastic part of the tibial plateau of this device.In August 2013 Waldemar Link issued a Field Safety Notice informing clinicians that they had received reports of wear of the plastic part of the metal-backed tibial plateau Endo-Model® 7mm.
    The manufacturer has informed the MHRA that the affected products have now been discontinued.A total of 9 cases of wear of the plastic part of the device were reported to the manufacturer from outside of the UK. The implant failures occurred between 6 months and 5 years after implantation and analysis of the returned explants showed significant plastic wear. A definitive root cause for the wear events has not been determined by the manufacturer.Wear of the plastic part of the plateau could lead to pain and stiffness. The debris generated by the wear could cause osteolysis, requiring device revision. In instances where wear leads to metal-on-metal contact, the resulting wear debris may lead to soft tissue damage requiring device revision.442 devices were distributed in the UK between 2003 and 2013.The MHRA is issuing this Medical Device Alert to ensure that clinicians are aware of this issue and consider appropriate follow up of patients implanted with affected devices.
  • Cause
    (waldemar link gmbh & company.Kg) consider annual review of patients for up to 5 years after implantation, including x-rays to detect progression of bearing wear. (mda/2014/018).
  • Action
    Identify patients implanted in the last 5 years with these devices. Consider annual review of patients for up to 5 years after implantation, including X-rays* to detect progression of bearing wear. Retain explanted devices to facilitate investigation by the manufacturer. Report all adverse events to the MHRA and to Waldemar Link. In all cases, the benefit of ionising radiation screening should be weighed against the risks from radiation exposure on an individual patient basis, in line with the requirements of The Ionising Radiation (Medical Exposure) Regulations 2000

Device

  • Modèle / numéro de série
  • Description du dispositif
    Unicondylar sled knee prosthesisMetal-backed tibial plateau Endo-Model® 7mmManufactured by Waldemar Link GmbH & Co. KGCatalogue numbers: 15-2030/01, 15-2030/05 and 15-2030/09.The metal-backed tibia plateau consists of a UHMWPE (plastic) part attached to a cobalt-chromium alloy (metal) plate. The total height of the tibial plateau is 7 mm.
  • Manufacturer

Manufacturer

  • Adresse du fabricant
    Dr Thomas Mehler Waldemar Link GmbH & Co. KGTel: +49 (0)40 53995-305 Email: t.mehler@linkhh.de
  • Société-mère du fabricant (2017)
  • Source
    MHRA