Events

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

According to Saudi Food & Drug Authority, this translation missing: en.activerecord.attributes.event.types.recall_field_safety_notice involved a device in Saudi Arabia that was produced by DePuy International Limited.

What is this?

Field safety notices are communications sent out by medical device manufacturers or their representatives in relation to actions that they may be taking in relation to their product that is on the market. These are mainly for health workers, but also for users. They can include recalls and alerts.

Learn more about the data here
  • Type of Event
    Recall / Field Safety Notice
  • Event ID
    mdprc 018 04 12 000
  • Event Initiated Date
    2012-04-03
  • Event Country
    Saudi Arabia
  • Event Source
    SFDA
  • Event Source URL
    https://ncmdr.sfda.gov.sa/Secure/CA/CaViewRecall.aspx?caid=5&rid=1649
  • Notes / Alerts
    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.
  • Extra notes in the data
    Report Source: NCAR
    SFDA urges all hospitals that have devices subjected to recall, to contact the company.
  • Reason
    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
  • Model / 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.
  • Product Description
    Hip implant
  • Manufacturer
    DePuy International Limited

Manufacturer

DePuy International Limited
  • Manufacturer Parent Company (2017)
    Johnson & Johnson
  • Manufacturers representative
    Johnson & Johnson Medical Meddile East, Riyadh, (01) 4603292
  • Source
    SFDA