Events

LCS COMPLETE RPS Knee System 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-2015-RN-00223-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2015-03-24
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-00223-1
  • 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
    Jjm was recently notified by the therapeutic goods administration (tga), that the lcs complete rps knee system has a higher rate of revision than the class of ps knee systems based on recent data from the aoanjrr. after further analysis of the aoanjrr data, depuy orthopaedics, inc (the manufacturer) determined that the lcs complete rps knee system has higher rates of revision in australia when the native patella is not resurfaced when compared to other unresurfaced ps implants. the need for a second surgery to resurface the native patella is due to an increased incidence of postoperative patello-femoral pain.
  • 조치
    Johnson & Johnson Medical is notifying surgeons of higher rates of revision in Australia when the native patella is not resurfaced when compared to other unresurfaced PS implants. Surgeons are advised that when using the LCS Complete RPS Knee System, the patella must be resurfaced. Johnson & Johnson Medical has also advised surgeons of the potential clinical implications for implanted LCS COMPLETE RPS Knee Systems where the native patella is not resurfaced.For further information https://www.tga.gov.au/alert/lcs-complete-rps-knee-system-used-knee-replacements. This action has been closed-out on 12/08/2016.

Device

LCS COMPLETE RPS Knee System

Manufacturer

Johnson & Johnson Medical Pty Ltd t/a DePuy Synthes