Events

Adept acetabular cups 를 위한 안전성 경고 / 현장 안전성 서한

Medicines and Healthcare products Regulatory Agency에 따르면, 해당 안전성 경고 / 현장 안전성 서한 는 United Kingdom 에서 Finsbury Orthopaedics 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
    Safety alert / Field Safety Notice
  • 사례 ID
    MDA/2007/067
  • 사례 연번
    CON2032218
  • 날짜
    2007-08-29
  • 사례 국가
    United Kingdom
  • 사례 출처
    MHRA
  • 사례 출처 URL
    https://webarchive.nationalarchives.gov.uk/20141206095400/http://www.mhra.gov.uk/PrintPreview/PublicationSP/CON2032218
  • 비고 / 경고
    Data from the United Kingdom is current through April 2019. All of the data comes from the Medicines and Healthcare products Regulatory Agency, 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 the United Kingdom.
  • 데이터 추가 비고
  • 원인
    Inappropriate mixing of head and cup sizes due to incorrect labelling of the cups. the need for early revision due to loose joint fit as a result of mislabelled cups. some acetabular cups manufactured by finsbury orthopaedics have been labelled with the wrong cup diameter. the manufacturer recalled affected products in august 2007 (see mhra website for field safety notice). the manufacturer has provided mhra with a list of uk affected products (see appendix). affected products were distributed to uk hospitals between 17/11/2006 and 19/02/2007.
  • 조치
    Identify and quarantine any unimplanted affected devices (see appendix). DO NOT implant affected devices. Return affected devices to the manufacturer. Review the post operative X-rays of these patients to identify size mismatch of head and cup. In patients with mismatched devices: consider the need for implant revision where implants are not being revised, consider measuring serial serum cobalt and chromium levels to monitor implant wear over time if monitoring reveals these levels are increasing, re-consider the need for implant revision. Set up systems to report all revisions with these incorrectly labelled cups to the implant manufacturer and the MHRA.

Device

Adept acetabular cups
  • 모델명 / 제조번호(시리얼번호)
  • 제품 설명
    Hip resurfacing implants. Adept acetabular cups manufactured by Finsbury Orthopaedics (see appendix for affected lot codes). Adept acetabular cups (48mm and 52mm). Affected UK lot codes (see appendix).
  • Manufacturer
    Finsbury Orthopaedics

Manufacturer

Finsbury Orthopaedics