Events

translation missing: fr.activerecord.attributes.event.titles.recall_field_safety_notice

Selon Saudi Food & Drug Authority, ce/cet/cette translation missing: fr.activerecord.attributes.event.types.recall_field_safety_notice concerne un dispositif en/au/aux/à Saudi Arabia qui a été fabriqué par DePuy International Limited.

Qu'est-ce que c'est?

Les avis de sécurité sont des communications que les fabricants de dispositifs médicaux ou leurs représentants font parvenir en particulier aux travailleurs du secteur médical, mais aussi aux utilisateurs de ces dispositifs. Les avis de sécurité concernent les actions entreprises quant aux dispositifs présents sur le marché et peuvent inclure des rappels et des alertes.

En savoir plus sur les données ici
  • Type d'événement
    Recall / Field Safety Notice
  • ID de l'événement
    mdprc 018 04 12 000
  • Date de mise en oeuvre de l'événement
    2012-04-03
  • Pays de l'événement
    Saudi Arabia
  • Source de l'événement
    SFDA
  • URL de la source de l'événement
    https://ncmdr.sfda.gov.sa/Secure/CA/CaViewRecall.aspx?caid=5&rid=1649
  • Notes / Alertes
    Saudi data is current through January 2019. All of the data comes from the Saudi Food & Drug Authority, 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 Saudi Arabia.
  • Notes supplémentaires dans les données
    Report Source: NCAR
    SFDA urges all hospitals that have devices subjected to recall, to contact the company.
  • Cause
    Analysis of data from the england and wales national joint registry (njr) up to 10 march 2012 has shown that the cumulative revision rate for mitch trh system used in hip resurfacing arthroplasty (revision rate of 3.1 % at 4 years based on 769 patients recorded by the njr) is in line with relevant guidance from the national institute for health and clinical excellence (nice) guidance,1,2 but that the cumulative revision rate for mitch trh system total hip replacements (revision rate of 8.8% at 4 years based on 445 patients recorded by the njr) is higher than indicated as acceptable by nice.

Device

Hip implant, Mitch TRH Acetabular Cup / Mitch TRH
  • Modèle / numéro de série
    Mitch TRH Acetabular Cup / Mitch TRH Modular Head (Finsbury Orthopaedics Ltd) when implanted with the uncemented Accolade femoral stem (Stryker). The system was manufactured by Finsbury Orthopaedics and was distributed in the UK by Stryker Orthopaedics between May 2006 and October 2011.
  • Description du dispositif
    Hip implant
  • Manufacturer
    DePuy International Limited

Manufacturer

DePuy International Limited
  • Société-mère du fabricant (2017)
    Johnson & Johnson
  • Représentant du fabricant
    Johnson & Johnson Medical Meddile East, Riyadh, (01) 4603292
  • Source
    SFDA