Events

LFIT Anatomic CoCr V40 Femoral Heads (Modular components used in total hip replacement procedures) 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Stryker Australia 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-2016-RN-01191-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2016-09-19
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-01191-1
  • 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
    Stryker has identified a non-conformance due to a trend analysis showing an incidence of taper lock failures higher than the predicted rate (>0.05%) for four lfit anatomic cocr v40 femoral heads manufactured prior to 2011. the increased incidence of taper lock failures relates to possible taper lock interface inconsistency. potential hazards include disassociation of femoral head from hip stem, fractured hip stem trunnion, increased metallic debris, insufficient range of motion, insufficient soft tissue tension, noise, loss of implant, bone fixation strength, increased wear debris (polymeric), implant construct with a shortened neck length.
  • 조치
    Stryker is advising that patients implanted with an affected lot number of the LFIT Anatomic CoCr V40TM Femoral Heads should continue to be followed per the normal protocol established by his/her surgeon.

Device

LFIT Anatomic CoCr V40 Femoral Heads (Modular components used in total hip replacement procedures)
  • 모델명 / 제조번호(시리얼번호)
    LFIT Anatomic CoCr V40 Femoral Heads (Modular components used in total hip replacement procedures)Item: 6260-9-236Head diameter 36mm; Offset +5Item: 6260-9-240Head diameter 40mm; Offset +4Item: 6260-9-244Head diameter 44mm; Offset +4Item: 6260-9-340Head diameter 40mm; Offset +8Item: 6260-9-440Head diameter 40mm; Offset +12Item: 6260-9-344Head diameter 44mm; Offset +8Item: 6260-9-444Head diameter 44mm; Offset +12Multiple lot numbers affected ARTG #: 211868
  • Manufacturer
    Stryker Australia Pty Ltd

Manufacturer

Stryker Australia Pty Ltd
  • 제조사 모회사 (2017)
    Stryker
  • Source
    DHTGA