Events

Avis De Sécurité sur Optipac bone cement

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
    2016-11-15
  • 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
    Optipac complaints were reviewed. the reported complaint rate for optipac is 0.0004% (for infections). it is up to the medical professional to evaluate whether a patient needs to be examined, but current results do not appear to require additional controls beyond the 2e standard.

Device

Optipac bone cement
  • Modèle / numéro de série
    Optipac Hipset Optipac 40 Refobacin Bone Cement R Optipac 60 Refobacin Bone Cement R Optipac 80 Refobacin Bone Cement R Optipac Softpac Hipset Optipac-S 40 Refobacin Bone Cement R Optipac-S 60 Refobacin Bone Cement R Optipac-S 80 Refobacin Bone Cement R Optipac Knee Refobacin Bone Cement R Optipac 40 Refobacin Plus Bone Cement Optipac 60 Refobacin Plus Bone Cement Optipac 80 Refobacin Plus Bone Cement Optipac-S Knee Refobacin Bone Cement R Optipac Softpac Refobacin Revision 40 Optipac-S 60 Refobacin Plus Bone Cement Optipac-S 80 Refobacin Plus Bone Cement Optipac Knee Refobacin Plus Bone Cement Optipac Refobacin Revision 40 Optipac Refobacin Revision 80 Optipac-S Knee Refobacin Plus Bone Cement Optipac-S 40 Refobacin Plus Bone Cement Optipac-S Refobacin Revision 80
  • 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