Events

Avenir Müller Stem 6 Lateral uncemented and Avenir Müller Stem 4 Standard uncemented (used as the component in total hip arthoplasty) 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Zimmer 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-00928-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2016-07-12
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-00928-1
  • 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
    The avenir müller stem 6 lateral uncemented may have been placed in the packaging of the avenir müller stem 4 standard uncemented and vice versa.The surgeon may have used a standard stem instead of a lateral stem. for the standard stem the offset is 6mm smaller and therefore an increased laxity of the hip might result. this could conduct to a risk of luxation, pain or revision surgery.
  • 조치
    Zimmer is advising users that use of a standard stem instead of a lateral stem may result in an increased laxity of the hip, and may result in pain or revision surgery. This action has been closed-out on 17/02/2017.

Device

Avenir Müller Stem 6 Lateral uncemented and Avenir Müller Stem 4 Standard uncemented (used as the...
  • 모델명 / 제조번호(시리얼번호)
    Avenir Müller Stem 6 Lateral uncemented and Avenir Müller Stem 4 Standard uncemented (used as the component in total hip arthoplasty)Avenir Müller Stem 6 Lateral uncemented Reference Number: 01.06010.106Lot Number: 4023094Avenir Müller Stem 4 Standard uncementedReference Number: 01.06010.004Lot Number: 4022860ARTG Number: 216175
  • Manufacturer
    Zimmer Pty Ltd

Manufacturer

Zimmer Pty Ltd
  • 제조사 모회사 (2017)
    Zimmer Biomet Holdings
  • 제조사 의견
    “The safety of patients has always been, and continues to be, Zimmer Biomet’s top priority and it is our honor to be a leader in this industry for the past 90 years,” Zimmer Biomet told ICIJ in a statement. “We adhere to strict regulatory standards, and work closely with the FDA and all applicable regulatory agencies in each of our regions as part of our commitment to operating a first-rate quality management system across our global manufacturing network. The company added that it is focused on staying at the forefront of innovation and doing right by the millions of patients who rely on the company’s products.
  • Source
    DHTGA