Events

Alerte De Sécurité sur Durom Acetabular Component

Selon Department of Health, ce/cet/cette alerte de sécurité concerne un dispositif en/au/aux/à Hong Kong qui a été fabriqué par Zimmer.

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
  • Date
    2012-11-01
  • Date de publication de l'événement
    2012-11-01
  • Pays de l'événement
    Hong Kong
  • Source de l'événement
    DH
  • URL de la source de l'événement
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20121101b.html
  • Notes / Alertes
    Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), 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 data from the U.S. and Hong Kong.
  • Notes supplémentaires dans les données
    Medical Device Safety Alert
  • Cause
    Medical device safety alert: zimmer durom acetabular component the therapeutic goods administration (tga), australia issued a medical device alert concerning durom acetabular component, manufactured by zimmer. the tga advised health professionals and patients that zimmer has cancelled the implant from the australian register of therapeutic goods (artg). the decision to cancel was based on an analysis of data collected by the australian national joint replacement registry (njrr), which revealed that the implant had a higher than expected revision rate. the 2011 njrr report revealed that the durom acetabular component's cumulative revision rate was 9.6% at 7 years in resurfacing applications (compared to 6.1% for all other similar implants) and 6.8% at 5 years in total conventional hip replacements (compared to 3.6% for all other similar implants). for details, please visit the following tga website: http://www.Tga.Gov.Au/safety/alerts-device-hip-dac-121030.Htm if you are in possession of the products, please contact your supplier for necessary actions. posted on 1 november 2012.

Device

Durom Acetabular Component
  • Modèle / numéro de série
  • Description du dispositif
    Medical Device Safety Alert: Zimmer Durom Acetabular Component
  • Manufacturer
    Zimmer

Manufacturer

Zimmer
  • 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
    DH