Events

Alerte De Sécurité sur DePuy ADEPT 12/14 Modular Head

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

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
    2013-01-22
  • Date de publication de l'événement
    2013-01-22
  • 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_20130122c.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 adept 12/14 modular head the medicines and healthcare products regulatory agency (mhra), united kingdom posted a medical device safety alert concerning adept 12/14 modular head, manufactured bydepuyorthopaedics(a johnson & johnson company). review of post‐market surveillance data suggests a higher than expected revision rate for the adept 12/14 modular head when used in conventional total hip arthroplasty. analysis of uk national joint registry supplier feedback data indicates a cumulative revision rate of 12.1% (95% ci 9.5% to 15.4%) at 7 years for the affected product when used in conventional total hip arthroplasty. in september 2012, the australian orthopaedic association national joint replacement registry reported a cumulative revision rate of 7.1% (95% ci 3.6% to 13.6%) at 3 years with 8 revisions in a cohort of 121 adept 12/14 modular head cases used in conventional total hip arthroplasty. the manufacturer advises that patients who have received the affected products should be followed according to local guidance/standard of care for patients receiving metal on metal (mom) articulations. also, refer to the local orthopaedic association for detailed information related to the treatment of patients with mom articulations. for details, please refer to mhra website: http://www.Mhra.Gov.Uk/safetyinformation/safetywarningsalertsandrecalls/ fieldsafetynotices/con224428 if you are in possession of the affected product, please contact your supplier for necessary actions. posted on 22 january 2013.

Device

DePuy ADEPT 12/14 Modular Head
  • Modèle / numéro de série
  • Description du dispositif
    Medical Device Safety Alert: DePuy ADEPT 12/14 Modular Head
  • Manufacturer
    DePuyOrthopaedics

Manufacturer

DePuyOrthopaedics