Events

DePuy S-ROM Noiles Rotating Hinge Femur with Pin (compatible with the MBT revision tibial tray) 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Johnson & Johnson Medical Pty Ltd T/A Depuy Australia 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-2014-RN-00355-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2014-03-26
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-00355-1
  • 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
    Johnson & johnson medical pty ltd has identified that there is potential for holes to develop in the inner and outer flexible pouches that form the sterile barrier for both the femur and the hinge pin, for all lots of depuy s-rom noiles rotating hinge femur with pin listed. the outer carton and shrink wrap are intact. the complaint rate for 2010 through 2013 is 0.35%. it is believed that these holes result from repeated shipments of the product in loan kits, over a number of years.
  • 조치
    The Operating Room staff/surgeon must be made aware of this potential issue. Prior to implantation, staff must inspect product packaging and if it is identified as having holes in one or both sterile pouches do not use the product and quarantine it. A second set of the DePuy S-ROM Noiles Rotating Hinge Femur with Pin will be sent to each case. S-ROM Noiles Rotating Hinge Femur with Pin devices without packaging breaches may continue to be used to avoid temporarily causing a sudden and complete lack of product availability and the bone loss associated with removing a well-fixed MBT Revision Tibial Tray. This action has been closed-out on 29/01/2016.

Device

DePuy S-ROM Noiles Rotating Hinge Femur with Pin (compatible with the MBT revision tibial tray)
  • 모델명 / 제조번호(시리얼번호)
    DePuy S-ROM Noiles Rotating Hinge Femur with Pin (compatible with the MBT revision tibial tray)Product Codes: 623401L, 623401R, 623411L, 623411R, 623421L, 623421RAll lots numbers affectedARTG 219088
  • Manufacturer
    Johnson & Johnson Medical Pty Ltd T/A Depuy Australia

Manufacturer

Johnson & Johnson Medical Pty Ltd T/A Depuy Australia