Events

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

Saudi Food & Drug Authority에 따르면, 해당 translation missing: ko.activerecord.attributes.event.types.recall_field_safety_notice 는 Saudi Arabia 에서 DePuy International Limited 에 의해 제조된 제품과 관련되어 있습니다.

이것은 무엇인가요?

현장 안전성 서한은 의료기기 제조사 또는 제조사 대리인이 시중에 유통되고 있는 자사 의료기기 제품에 대하여 취할 수 있는 조치를 알리는 소통방식입니다. 주요 대상층은 보건의료업계 종사자와 의료기기 사용자들입니다. 여기에는 회수(recall) 조치와 경고도 포함될 수 있습니다.

데이터에 대해 더 자세히 알아보기 여기
  • 사례 유형
    Recall / Field Safety Notice
  • 사례 ID
    mdprc 018 04 12 000
  • 사례 시작날짜
    2012-04-03
  • 사례 국가
    Saudi Arabia
  • 사례 출처
    SFDA
  • 사례 출처 URL
    https://ncmdr.sfda.gov.sa/Secure/CA/CaViewRecall.aspx?caid=5&rid=1649
  • 비고 / 경고
    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.
  • 데이터 추가 비고
    Report Source: NCAR
    SFDA urges all hospitals that have devices subjected to recall, to contact the company.
  • 원인
    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
  • 모델명 / 제조번호(시리얼번호)
    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.
  • 제품 설명
    Hip implant
  • Manufacturer
    DePuy International Limited

Manufacturer

DePuy International Limited
  • 제조사 모회사 (2017)
    Johnson & Johnson
  • 제조사 대표
    Johnson & Johnson Medical Meddile East, Riyadh, (01) 4603292
  • Source
    SFDA