balanSys UNI convex PE inlay x/6, x/7, x/9 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Mathys Orthopaedics 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-2018-RN-00096-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2018-02-14
  • 사례 국가
  • 사례 출처
    DHTGA
  • 사례 출처 URL
  • 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
    Global post market surveillance data showed two (2) reports from 2016 and 2017 concerning in situ inlay breakage of balansys uni convex pe inlays x/6 after approximately eight years. in 2015 mathys ltd bettlach made the decision to phase-out the balansys uni convex unicompartmental knee system based on economic grounds, with only the uni convex pe inlays to be retained to allow for potential minor revision surgeries. the phase out was initiated in december 2015, and completed by december 2016. in november 2016, a field safety corrective action was carried out to recall all balansys uni convex pe inlays x/5 (thickness 5 mm) from the market after the occurrence of seven (7) breakages of the inlays x/5. no events have been reported for x/7 and x/9.
  • 조치
    Mathys Orthopaedics is advising surgeons to inform affected patients implanted with a size x/6, x/7 and x/9 inlay about the risks of PE inlay breakage and any further associated potential risks while maintaining their routine follow-up protocol. The need for any additional follow-up or revision surgery should be determined on a case-by-case basis following a detailed assessment of each patients’ clinical circumstances.

Device

  • 모델명 / 제조번호(시리얼번호)
    balanSys UNI convex PE inlay x/6, x/7, x/9Multiple affected Art Numbers - all lots of these are affectedARTG Number: 212828 - cancelled
  • Manufacturer

Manufacturer