Events

Zimmer Segmental System Polyethylene Insert-Size B & Size C (Intended to replace the proximal femur, mid-shaft femur, distal femur, proximal tibia and/or total knee in cases that require extensive resection and restoration) 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-2014-RN-00111-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2014-02-05
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-00111-1
  • 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
    Zimmer has received 13 complaints since 2007 related to hyper-extension. this represents a complaint rate of approximately 0.4%. of the 13 complaints there were 9 patients involved due to repeat occurrences with multiple patients. in addition, analysis of the explanted polyethylene insert found that it typically exhibited anterior deformation in these 9 patients. based on the investigation of these complaints, zimmer determined that updates to the labelling associated with the zimmer segmental system were required to provide additional instructions and patient conditions that may place excessive loading on the polyethylene insert.
  • 조치
    Zimmer is updating the applicable surgical technique (97-5850-004-00) and instructions for use (87-6203-755-23) and is advising surgeons that if a patient is symptomatic with instability or pain associated with hyperextension of approximately 15 degrees or more, surgeon evaluation is recommended. Zimmer is also working on an enhanced design that will be offered in addition to the current polyethylene inserts.

Device

Zimmer Segmental System Polyethylene Insert-Size B & Size C (Intended to replace the proximal fem...
  • 모델명 / 제조번호(시리얼번호)
    Zimmer Segmental System Polyethylene Insert-Size B & Size C (Intended to replace the proximal femur, mid-shaft femur, distal femur, proximal tibia and/or total knee in cases that require extensive resection and restoration) Item Numbers: 00-5850-012-95 & 00-5850-013-95ARTG Number: 198424
  • 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