Events

Ascension PyroTitan Humeral Resurfacing Arthroplasty components 의 리콜

New Zealand Medicines and Medical Devices Safety Authority에 따르면, 해당 리콜 는 New Zealand 에서 Ascension Orthopedics Inc 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
    15219
  • 사례 시작날짜
    2013-08-30
  • 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: LMT Surgical, 9 Business Connection, 2 Kalmia Street, Ellerslie Greenlane, Auckland 1544
  • 원인
    The manufacturer, ascension orthopaedics, has received complaints of implant fractures that were observed post-operatively and required revision surgeries. most confirmed cases of implant breakage have occurred as a result of excessive loading and within a year of being implanted. excessive loads placed on the implant through high impact activities or sudden trauma can damage an artificial joint, particularly in the presence of poor bone stock. high impact activity may cause loosening or fracture of the implant. the breakage can result in glenohumeral joint pain and possible damage to the surrounding tissues.
  • 조치
    Manufacturer to issue advice regarding use

Device

Ascension PyroTitan Humeral Resurfacing Arthroplasty components

Manufacturer

Ascension Orthopedics Inc