Events

Alerte De Sécurité sur Cemented, Polished and Cobalt Chromium Alloy Hip Stems

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

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
    2012-05-03
  • Date de publication de l'événement
    2012-05-03
  • 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_20120503f.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: depuy cemented, polished and cobalt chromium alloy hip stems it comes to our attention that medical device manufacturer, depuy (a johnson & johnson company) has issued a field safety notice concerning depuy cemented, polished and cobalt chromium alloy hip stems. in 2007, depuy issued a letter to ultima tps cemented polished cobalt chromium (cocr) hip stem users in the united kingdom (uk) to inform them of a potential association between extensive peri-prosthetic soft tissue necrosis and hip stem implantation with the ultima metal-on metal (mom). following research activities undertaken by depuy, it was concluded that when used in combination with a mom articulation of an all metal type, depuy’s cemented, polished, cocr femoral hip stems, including the depuy g2 and fjord cemented femoral hip stems could potentially exhibit corrosion of the polished surfaces which are within the cement mantle. this corrosion may in turn lead to an increased incidence of peri-prosthetic soft tissue necrosis. therefore, depuy advises against the implantation of the following configuration: depuy’s cemented, polished, cocr alloy femoral hip stems combined with mom articulation. according to the local supplier, ultima tps, depuy g2 and fjord cemented femoral hips stems have not been distributed in hong kong. if you are in possession of the affected products, please contact your supplier for necessary actions. posted 03 may 2012.

Device

Cemented, Polished and Cobalt Chromium Alloy Hip Stems
  • Modèle / numéro de série
  • Description du dispositif
    Medical Device Safety Alert: DePuy Cemented, Polished and Cobalt Chromium Alloy Hip Stems
  • Manufacturer
    DePuy

Manufacturer

DePuy