Events

GENESIS II KNEE SYSTEM – Non Porous Tibial Base Plate 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Smith & Nephew Surgical 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-2015-RN-00154-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2015-02-24
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-00154-1
  • 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
    Batch number 14ct39993 of the genesis ii knee system non-porous tibial base plate (model # 71420182) were manufactured with a surface finish that does not meet smith & nephew’s product specification. this could result in poor cement adherence and the loosening of base plate. the device may fail, and revision surgery may be required.
  • 조치
    Smith & Nephew is recommending that surgeons follow standard post-operative follow-up protocols and actions for their patients and ensure that patients are informed about symptoms (particularly pain and knee instability) that might indicate the need for implant review or revision surgery, and the need to seek follow up care should these symptoms arise. For further information please see https://www.tga.gov.au/alert/genesis-ii-knee-system-non-porous-tibial-baseplate-used-knee-replacement. This action has been closed-out on 22/08/2016.

Device

GENESIS II KNEE SYSTEM – Non Porous Tibial Base Plate
  • 모델명 / 제조번호(시리얼번호)
    GENESIS II KNEE SYSTEM – Non Porous Tibial Base Plate Model Number: 71420182 Batch Number: 14CT39993ARTG Number: 207027
  • Manufacturer
    Smith & Nephew Surgical Pty Ltd

Manufacturer

Smith & Nephew Surgical Pty Ltd