Events

Muliple Zimmer Highly Polished Implants (packaged in a Low Density Polyethylene (LDPE) Bag) 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-2013-RN-00985-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2013-09-25
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2013-RN-00985-1
  • 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
    Residue or pieces of film from the ldpe bag containing the implant may adhere to the highly polished implant surface. the frequency of this occurrence is approximately 1 in 8000 cases. in a small number of these cases the affected device was implanted. testing and analysis were conducted to evaluate potential risks such as abrasive wear, mechanical integrity and biocompatibility. these evaluations concluded that it is unlikely that adhesion of the ldpe bag would cause an adverse effect to either the patient or function of the implant because:-the ldpe material is biocompatible, similar to the ultra high molecular weight polyethylene (uhmwpe).-ldpe is softer than the two mating material of uhmwpe & cobalt chrome molybdenum. therefore, is not expected to scratch either wear surface, which could increase wear rates and lead to osteolysis.-if there were wear particulates generated from the ldpe bag, they would be expected to elicit similar reactions as those from uhmwpe.
  • 조치
    Zimmer is advising users to examine potentially affected implants prior to use. Should a user encounter adhesion of a LDPE bag to a implant during surgery, it is recommended that the implant not be used. The implant can be returned to a Zimmer sales representative.

Device

Muliple Zimmer Highly Polished Implants (packaged in a Low Density Polyethylene (LDPE) Bag)
  • 모델명 / 제조번호(시리얼번호)
    Muliple Zimmer Highly Polished Implants (packaged in a Low Density Polyethylene (LDPE) Bag)All lots manufactured prior to 1 April 2013Multiple products affectedMultiple Part Numbers affectedARTG Numbers: 95692, 208688, 99906, 95760, 115909
  • 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