Events

Alerte De Sécurité sur Shoulder Implants

Selon National Institute of Drugs and Food Surveillance (INVIMA), ce/cet/cette alerte de sécurité concerne un dispositif en/au/aux/à Colombia qui a été fabriqué par Biomet Orthopedics Inc. || Zhejiang Biomet Medical Products Co., Ltd..

Qu'est-ce que c'est?

Les alertes fournissent des informations importantes et des recommandations concernant les dispositifs médicaux. Le fait qu'une alerte soit émise ne signifie pas nécessairement qu'un dispositif soit dangereux. Les alertes de sécurité, qui sont envoyées tant aux travailleurs du secteur médical qu'aux utilisateurs de ces dispositifs, peuvent inclure des rappels. Elles peuvent être rédigées par des fabricants mais aussi par des autorités en charge de la santé.

En savoir plus sur les données ici
  • Type d'événement
    Safety alert
  • ID de l'événement
    R1702-57
  • Numéro de l'événement
    2009DM-0004137
  • Date
    2017-02-17
  • Pays de l'événement
    Colombia
  • Source de l'événement
    INVIMA
  • URL de la source de l'événement
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=102
  • Notes / Alertes
    Colombian data is current through June 2019. All of the data comes from the National Institute of Drugs and Food Surveillance (INVIMA), 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 Colombia.
  • Notes supplémentaires dans les données
  • Cause
    The manufacturer states that it has detected that the referenced devices manufactured before september 2011 may have a higher breakage rate than expected, those manufactured after this date have design improvements that increased their resistance, this situation may lead to possible adverse events on the patients.

Device

Shoulder Implants
  • Modèle / numéro de série
  • Classification du dispositif
    Orthopedic Devices
  • Description du dispositif
    Indicated in cases of non-inflammatory joint degenerative disease such as osteoarthritis and avascular necrosis. Rheumatoid arthritis. Correction of functional deformity. Fractures of the proximal humerus. Clinical control problems difficult to administer that includes fist arthropathy.
  • Manufacturer
    Biomet Orthopedics Inc. || Zhejiang Biomet Medical Products Co., Ltd.

Manufacturer

Biomet Orthopedics Inc. || Zhejiang Biomet Medical Products Co., Ltd.
  • 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
    NIDFSINVIMA