Events

S&N Birmingham Hip Modular Head, 36mm to 62mm 의 리콜

New Zealand Medicines and Medical Devices Safety Authority에 따르면, 해당 리콜 는 New Zealand 에서 Smith & Nephew Orthopaedics 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
    18345
  • 사례 시작날짜
    2015-04-16
  • 사례 국가
    New Zealand
  • 사례 출처
    NZMMDSA
  • 사례 출처 URL
    https://medsafe.govt.nz/hot/Recalls/RecallSearch.asp
  • 비고 / 경고
    Data from New Zealand is current through July 2018. All of the data comes from the New Zealand Medicines and Medical Devices Safety Authority, 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 New Zealand.
  • 데이터 추가 비고
    Recalling Organisation: Smith & Nephew Surgical Ltd, Unit A 36 Hillside road, Wairau Valley, AUCKLAND 0760
  • 원인
    In october 2012, smith & nephew issued a hazard alert informing surgeons and hospitals that the birmingham hip™ modular head had been identified in the australian national joint replacement registry (njrr) and the national joint registry of england and wales (njrew) as having a higher than expected revision rate when compared to all other total conventional hip replacements. in late 2014, smith & nephew became aware of new information relating to the performance of bhmh. also, recent registry and clinical data has showed a decline in the performance of the bhmh., based on the analysis of this information, smith & nephew considers that patients implanted with the bhmh device may be at greater risk of revision surgery.
  • 조치
    Manufacturer to issue advice regarding use

Device

S&N Birmingham Hip Modular Head, 36mm to 62mm
  • 모델명 / 제조번호(시리얼번호)
    Model: Catalogue Numbers: 74222138, 74222140, 74222142, 74222144, 74222146, 74222148, 74222150, 74222152, 74222154, 74222156, 74222158, 74222160, 74222162, Affected: All lots
  • Manufacturer
    Smith & Nephew Orthopaedics Ltd

Manufacturer

Smith & Nephew Orthopaedics Ltd