Events

M2a 38 Acetabular Cup, M2a 38 Femoral Head, M2a Magnum Tri-Spike Acetabular Cup & M2a Magnum Femoral Heads 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Biomet Australia 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-2015-RN-00100-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2015-02-06
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-00100-1
  • 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
    Biomet australia has initiated this hazard alert following analysis of data collected by the australian national joint replacement registry (njrr) which revealed that these specific implants have a higher than expected revision rate when used as part of metal on metal (mom) total conventional hip arthroplasty constructs.Use of these implants has declined since 2008, with the last use of these implants in metal on metal total hip replacements (thrs) recorded in 2011. it is important to note that this hazard alert does not relate to the use of the magnum acetabular cup in combination with the active articulation dual mobility hip bearing system which is a polyethylene/metal construct.
  • 조치
    M2A 38 system and M2a Magnum Femoral Head are in the process of being cancelled from the Australian Register of Therapeutic Goods (ARTG). Surgeons are advised that patients who have received a MoM implant require careful, specific follow up, particularly if the implant is known to have a higher than expected rate of revision as in this case. Biomet is referring surgeons to the 'Recommendations for follow-up of patients with metal-on-metal hip implants' published in the TGA website. For more details, please see https://www.tga.gov.au/alert/biomet-m2a-metal-metal-total-hip-replacement-implants. This action has been closed-out on 03/08/2016.

Device

M2a 38 Acetabular Cup, M2a 38 Femoral Head, M2a Magnum Tri-Spike Acetabular Cup & M2a Magnum Femo...
  • 모델명 / 제조번호(시리얼번호)
    M2a 38 Acetabular Cup, M2a 38 Femoral Head, M2a Magnum Tri-Spike Acetabular Cup & M2a Magnum Femoral Heads ARTG Numbers: 98098 & 117715
  • Manufacturer
    Biomet Australia Pty Ltd

Manufacturer

Biomet Australia 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