Events

Apex K2 Modular Hip Replacement System (total joint prosthesis) 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Global Orthopaedic Technology Pty Ltd 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-2012-RN-01012-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2012-10-18
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2012-RN-01012-1
  • 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 annual reports of the australian national joint registry [njrr], have indicated a higher than expected revision rate for this prosthesis since 2010. the 2011 njrr report indicated that the cumulative revision rate for the device was 5.2% at 1 year from the time of implantation, and a headline revision rate of 4.6 revisions per 100 observed years. the revision rate for the implant continues to be higher than that of similar implants being used in australia. the apex k2 stem has not been available for implantation since early october 2011.This device has now also been cancelled from the australian register of therapeutic goods as well as the private hospital prosthesis list.
  • 조치
    Global Orthopaedic Technology is advising implanting/treating surgeons on how to manage patients implanted with Apex K2 Femoral Stem. For more details, please see http://www.tga.gov.au/safety/alerts-device-hip-apex-k2-121030.htm

Device

Apex K2 Modular Hip Replacement System (total joint prosthesis)
  • 모델명 / 제조번호(시리얼번호)
    Apex K2 Modular Hip Replacement System (total joint prosthesis)Multiple Catalogue NumbersPrevious ARTG Number: 149020
  • Manufacturer
    Global Orthopaedic Technology Pty Ltd

Manufacturer

Global Orthopaedic Technology Pty Ltd