Events

PyroTITAN Humeral Resurfacing Arthroplasty (CHRA) 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 LMT Surgical 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-00761-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2013-08-08
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2013-RN-00761-1
  • 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 manufacturer, ascension orthopedics, has received complaints of implant fractures that were observed post-operatively and required revision surgeries. most confirmed cases of implant breakage have occurred as a result of excessive loading and within a year of being implanted. excessive loads placed on the implant through high impact activities or sudden trauma can damage an artificial joint, particularly in the presence of poor bone stock. high impact activity may cause loosening or fracture of the implant. the breakage can result in glenohumeral joint pain and possible damage to the surrounding tissues.
  • 조치
    The implanting surgeons are advised that the affected patients should be followed up in accordance to standard clinical practices with radiographic evaluation of the shoulder being conducted at each follow-up visit. LMT Surgical Pty Ltd is advising that future supply of the product in Australia will not occur before appropriate corrective actions are implemented. It is expected that this corrective action will take several months to complete. For more details, see http://www.tga.gov.au/safety/alerts-device-pyrotitan-130812.htm

Device

PyroTITAN Humeral Resurfacing Arthroplasty (CHRA)
  • 모델명 / 제조번호(시리얼번호)
    PyroTITAN Humeral Resurfacing Arthroplasty (CHRA) Product Codes:CHRA-910-38/14-WW (Size 38-14)CHRA-910-41/15-WW (Size 41-15)CHRA-910-41/18-WW (Size 41-18)CHRA-910-44/16-WW (Size 44-16)CHRA-910-44/19-WW (Size 44-19)CHRA-910-44/17-WW (Size 47-17)CHRA-910-47/20-WW (Size 47-20)CHRA-910-50/18-WW (Size 50-18)CHRA-910-50/21/WW (Size 50-21)CHRA-910-53/19-WW (Size 53-19)CHRA-910-53/22-WW (Size 53-22)CHRA-910-56/21-WW (Size 56-21)ARTG: 149178
  • Manufacturer
    LMT Surgical Pty Ltd

Manufacturer

LMT Surgical Pty Ltd