Events

Birmingham Hip Product Range BHR Resurfacing Head BHR Acetabular CupCHR Dysplasia Cup BIRMINGHAM HIP Modular Head Sleeved 38MM~62MM 12/14 Modular Taper Sleeve BIRMINGHAM HIP Modular Head Monoblock 38MM~58MM 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Smith & Nephew 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-00436-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2016-05-03
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-00436-1
  • 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
    Smith & nephew is issuing an update to a medical device hazard alert issued in 2015 to provide surgeons and hospitals with updated information on the birmingham hip resurfacing (‘bhr’) product range and the birmingham hip modular head (bhmh) system. this update contains a current summary of the information concerning the revision rates of various products in the bhr and bhmh systems (including the monoblock version of the bhmh system).
  • 조치
    The sponsor is recommending that physicians maintain their routine follow-up protocol for patients who have undergone THA. Patients who experience symptoms including pain, swelling, enlarged bursae, pseudo-tumours, tissue masses, fluid collections, or local build-up of excessive metal particles or metal hypersensitivity, may require revision surgery, with attendant risks and the potential for impaired function. The need for any additional follow-up, including the necessity for diagnostic imaging and blood tests, should be determined on a case-by-case basis following a detailed assessment of the patients’ clinical circumstances. This action has been closed-out on 24/05/2017.

Device

Birmingham Hip Product Range BHR Resurfacing Head BHR Acetabular CupCHR Dysplasia Cup BIRMINGHAM ...
  • 모델명 / 제조번호(시리얼번호)
    Birmingham Hip Product RangeBHR Resurfacing HeadBHR Acetabular CupCHR Dysplasia CupBIRMINGHAM HIP Modular Head Sleeved 38MM~62MM 12/14 Modular Taper SleeveBIRMINGHAM HIP Modular Head Monoblock 38MM~58MMMultiple Catalogue Numbers affectedAll batches affectedARTG Numbers:120078, 124099, 124100
  • Manufacturer
    Smith & Nephew Pty Ltd

Manufacturer

Smith & Nephew Pty Ltd