Events

Avis De Sécurité sur Oxford cementless prosthetic knee prosthesis system

Selon Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI), ce/cet/cette avis de sécurité concerne un dispositif en/au/aux/à Slovenia qui a été fabriqué par Zimmer Biomet.

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
    Field Safety Notice
  • Date
    2017-03-28
  • Pays de l'événement
    Slovenia
  • Source de l'événement
    AMPMDRS
  • Notes / Alertes
    Data from Slovenia is current through February 2019. All of the data comes from the Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI), 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 Slovenia.
  • Notes supplémentaires dans les données
  • Cause
    An analysis showed 0.12% of cases in patients worldwide who had fractures of the tibial plateau. an analysis of reported complaints has yielded results showing that, in the event of a fracture, tibia was identified by the orthopedic surgeon on average 25 days after the primary surgery, and available data indicates that 17% of these fractures were treated conservatively. the cementless oxford tibial trays were manufactured according to predefined specifications. an investigation into the cause of reported tibial plateau fractures has shown that it is important to follow certain steps outlined in current surgical techniques to reduce the risk of tibial plateau fractures. this notice seeks to emphasize the importance of adhering to the applicable surgical technique and the relevant sections in the package leaflet.

Device

Oxford cementless prosthetic knee prosthesis system
  • Modèle / numéro de série
    Article Number Batch numbers 166570, 166571, 166845, 166846, 166572, 166573, 166574, 166575, 166576, 166577, 166578, 166579, __ 166580, 166581 V39 serue 154913,154914,154915,154916,154917,154918, 154919,154920,154921,154922,154923,154924 \ lse serue USl66570, U5166571, U3166845, U5166846, U5166572, USl66573, USl66574, U5166575, U5166576, USl66577, U5166578, U5166579, \ lse serue U5166580, U5166581
  • Manufacturer
    Zimmer Biomet

Manufacturer

Zimmer Biomet
  • Société-mère du fabricant (2017)
    Zimmer Biomet Holdings
  • Commentaire du fabricant
    “The safety of patients has always been, and continues to be, Zimmer Biomet’s top priority and it is our honor to be a leader in this industry for the past 90 years,” Zimmer Biomet told ICIJ in a statement. “We adhere to strict regulatory standards, and work closely with the FDA and all applicable regulatory agencies in each of our regions as part of our commitment to operating a first-rate quality management system across our global manufacturing network. The company added that it is focused on staying at the forefront of innovation and doing right by the millions of patients who rely on the company’s products.
  • Source
    AMPMDRS