Events

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

Según Saudi Food & Drug Authority, este evento ( translation missing: es.activerecord.attributes.event.types.recall_field_safety_notice ) involucró a un dispositivo médico en Saudi Arabia que fue producido por DePuy International Limited.

¿Qué es esto?

Las notificaciones de seguridad de campo son comunicaciones sobre acciones que se pueden estar tomando en relación con un producto que se encuentra en el mercado, enviadas por los fabricantes de dispositivos médicos o sus representantes. Estas notificaciones son principalmente para trabajadores de la salud, pero también para usuarios. Pueden incluir alertas y retiro de equipos.

Más información acerca de la data acá
  • Tipo de evento
    Recall / Field Safety Notice
  • ID del evento
    mdprc 018 04 12 000
  • Fecha de inicio del evento
    2012-04-03
  • País del evento
    Saudi Arabia
  • Fuente del evento
    SFDA
  • URL de la fuente del evento
    https://ncmdr.sfda.gov.sa/Secure/CA/CaViewRecall.aspx?caid=5&rid=1649
  • Notas / Alertas
    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.
  • Notas adicionales en la data
    Report Source: NCAR
    SFDA urges all hospitals that have devices subjected to recall, to contact the company.
  • Causa
    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
  • Modelo / Serial
    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.
  • Descripción del producto
    Hip implant
  • Manufacturer
    DePuy International Limited

Manufacturer

DePuy International Limited
  • Empresa matriz del fabricante (2017)
    Johnson & Johnson
  • Representante del fabricante
    Johnson & Johnson Medical Meddile East, Riyadh, (01) 4603292
  • Source
    SFDA