Events

Journey BCS Knee System - Femoral Components Journey BCS CoCr Femoral Component Journey BCS Oxinium Femoral Component Journey BCS Tibial InsertAll Batch/Lot Numbers 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Smith & Nephew 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-2018-RN-00859-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2018-07-02
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2018-RN-00859-1
  • 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
    In january 2014, smith & nephew issued a hazard alert for the journey bcs knee system (tga ref: rc-2014-rn-00004-1) which informed surgeons of the higher than expected revision rate identified by the aoanjrr and advised of the withdrawal of the journey bcs femoral component for primary surgery from the australian market.Smith & nephew is now issuing an update following an analysis of the national joint registry of england, wales & northern ireland (njrewni) & australian orthopaedic association national joint replacement registry (aoanjrr) data on the 1st generation journey bcs knee system.The journey bcs tibial insert remains available for use but should only be used for polyethylene exchange revision of first generation journey bcs total knee constructs where the femoral component and tibial baseplate are well fixed.
  • 조치
    Surgeons should maintain their routine follow-up protocol for patients who have undergone total knee arthroplasty. Signs and symptoms to consider for potential revisions are no different from those that might be reported by any patient having undergone primary total knee arthroplasty. The need for revision should be determined on a case-by-case basis following a detailed assessment of each patient’s clinical circumstances. Smith & Nephew is not recommending pro-active revision surgeries for patients implanted with this device.

Device

Journey BCS Knee System - Femoral Components Journey BCS CoCr Femoral Component Journey BCS Oxini...
  • 모델명 / 제조번호(시리얼번호)
    Journey BCS Knee System - Femoral ComponentsJourney BCS CoCr Femoral ComponentJourney BCS Oxinium Femoral ComponentJourney BCS Tibial InsertAll Batch/Lot NumbersMultiple Catalogue NumbersARTG Number: 278110(Smith & Nephew Pty Ltd - JOURNEY BCS Articular Insert - Prosthesis, internal, joint, knee, tibial component)
  • Manufacturer
    Smith & Nephew Pty Ltd

Manufacturer

Smith & Nephew Pty Ltd