Events

SIGMA HP PFJ Cemented Trochlear Implants 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Johnson & Johnson Medical Pty Ltd t/a DePuy Synthes 에 의해 제조된 제품과 관련되어 있습니다.

이것은 무엇인가요?

의료기기에 문제가 생겼을 경우 제조사가 이를 바로잡거나 시장에서 회수하는 조치를 말한다. 회수(Recall)는 의료기기에 결함이 있거나, 건강에 위협이 되거나, 또는 결함도 있고 건강에도 위협이 될 경우에 발생한다.

데이터에 대해 더 자세히 알아보기 여기
  • 사례 유형
    Recall
  • 사례 ID
    RC-2018-RN-00005-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2018-01-09
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2018-RN-00005-1
  • 비고 / 경고
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 Australia.
  • 데이터 추가 비고
  • 원인
    The manufacturer, depuy orthopaedics, inc. is voluntarily recalling the sigma hp pfj cemented trochlear implants, which is a standalone component of the partial knee system. this decision is based on elevated revision rates observed as part of the company’s post market surveillance process. further distribution or use of the affected implants is to cease immediately, and the product is now discontinued. the company recommends that surgeons use alternative implants or consider a total knee replacement.
  • 조치
    DePuy is advising Recipients are requested to return a copy of the completed acknowledgement form as directed in the Hazard Alert and to forward this notice to anyone who needs to be informed. DePuy Orthopaedics, Inc. is not recommending prophylactic revision in the absence of symptoms. The company recommends that surgeons discuss potential clinical implications and risks with symptomatic patients who received the affected implants.

Device

SIGMA HP PFJ Cemented Trochlear Implants

Manufacturer

Johnson & Johnson Medical Pty Ltd t/a DePuy Synthes