Events

Avis De Sécurité sur SIGMA® High Performance (HP) MBT Non-Keel Punch Knee Instrument

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 DePuy Synthes.

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
  • 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
    At depuy orthopedics, inc., we have decided to voluntarily recall ten batches of sigma® high performance (hp) mbt non-keel punch knee instrument (see figure 1). please stop distributing and using contested lots. we challenged the challenged product series because of a change in design that resulted in an unanticipated increase in the height of the instrument. therefore, it is possible for the surgeon to choose an implant that is too narrow during the trial implant placement procedure (see figure 2).

Device

SIGMA® High Performance (HP) MBT Non-Keel Punch Knee Instrument

Manufacturer

DePuy Synthes