Events

Rappel Ou Alerte De Sécurité sur ASR XL Acetabular System & DePuy ASR Hip Resurfacing system

Selon Central Drugs Standard Control Organization, ce/cet/cette rappel ou alerte de sécurité concerne un dispositif en/au/aux/à India qui a été fabriqué par DePuy International Limited.

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
    Recall / Safety Alert
  • ID de l'événement
    31-132-MD/2006-DC (Re. Reg. 2009)
  • Date
    2013-12-09
  • Pays de l'événement
    India
  • Source de l'événement
    CDSCO
  • URL de la source de l'événement
    https://web.archive.org/web/20180304060129/http://www.cdsco.nic.in/forms/list.aspx?lid=1862&Id=1
  • Notes / Alertes
    The data from India is current through 2017. All of the data comes from the Central Drugs Standard Control Organization, 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 India.
  • Notes supplémentaires dans les données
  • Cause
    Recall of asr hip replacement implants due to increased rates of revision.
  • Action
    - Do not implant DePuy ASR hip replacements. - Return all unused ASR hip replacement implants to the manufacturer. - Inform all patients implanted with ASR hip replacements about this recall and schedule them for a follow-up visit. - Follow up all patients implanted with ASR hip replacements with clinical examination at least annually. - For patients presenting with symptoms of abnormal pain, limping, swelling around the hip, deteriorating hip function or radiological abnormality: * consider measuring cobalt and chromium ion levels in whole blood and/or performing cross sectional imaging including MRI or ultrasound scan. * If metal ion levels in whole blood are elevated above 120 nmol/L (cobalt) or 135 nmol/L (chromium) [ie seven parts per billion (ppb) for either metal ion], a second test should be performed three months after the first in order to identify patients who require closer surveillance, which may include cross sectional imaging. * If MRI or ultrasound scan reveals soft tissue reactions, fluid collections or tissue masses then consider revision surgery.

Device

ASR XL Acetabular System & DePuy ASR Hip Resurfacing system

Manufacturer

DePuy International Limited