Events

Orthopaedic implant rHead Radial Head and Uni-Elbow 를 위한 안전성 경고 / 현장 안전성 서한

Medicines and Healthcare products Regulatory Agency에 따르면, 해당 안전성 경고 / 현장 안전성 서한 는 United Kingdom 에서 Stryker 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
  • 날짜
    2019-02-08
  • 사례 출판 날짜
    2019-02-08
  • 사례 국가
    United Kingdom
  • 사례 출처
    MHRA
  • 사례 출처 URL
    https://www.gov.uk//drug-device-alerts/orthopaedic-implant-rhead-radial-head-and-uni-elbow-risk-of-early-loosening-mda-2019-006
  • 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
    Stryker issued a Field Safety Notice dated November 2017 informing clinicians of the recall of the rHead Radial Head and Uni-Elbow prosthesis. The manufacturer identifies the possibility of post-operative implant loosening (septic and aseptic), instability (moderate/severe), stress fracture (bone), cyst formation (bone resorption), stiffness, pain, impingement, heterotopic ossification with these devices.This Medical Device Alert is being issued to ensure that all hospitals are aware of the issue and that adequate action is taken to mitigate potential risk to patients.
  • 원인
    Manufactured by stryker – post-operative loosening of the implant which may require revision surgery.
  • 조치
    Do not implant these devices (see details below) Identify and quarantine all affected devices Identify and advise all patients implanted with affected devices to contact their orthopaedic surgeon if they develop symptoms such as pain, loss of function or instability. Follow actions recommended in the manufacturer’s Field Safety Notice Report all adverse events involving this device to Stryker and through your local incident reporting system and/or your national incident reporting authority as appropriate: England, Scotland, Northern Ireland, Wales.

Device

Orthopaedic implant rHead Radial Head and Uni-Elbow
  • 모델명 / 제조번호(시리얼번호)
  • 제품 설명
    All lots of the Stryker rHead Radial Head and Uni-Elbow are affected.The manufacturer’s Field Safety Notice has details of the affected part numbers.
  • Manufacturer
    Stryker

Manufacturer

Stryker
  • 제조사 주소
    Stryker GmbH c/o Stryker T&E Post Market Safety Bohnackerweg 1 CH – 2545 Selzach SwitzerlandTel: +41 (0)79 904 3871tnepfa@stryker.com
  • 제조사 모회사 (2017)
    Stryker
  • Source
    MHRA