Events

ASR XL Acetabular System & DePuy ASR Hip Resurfacing system 를 위한 리콜 또는 안전성 경고

Central Drugs Standard Control Organization에 따르면, 해당 리콜 또는 안전성 경고 는 India 에서 DePuy International Limited 에 의해 제조된 제품과 관련되어 있습니다.

이것은 무엇인가요?

안전성 경고는 의료기기 제품과 관련된 중요한 정보와 권고사항을 담고 있습니다. 물론 안전성 경고가 배포되었다고 해서 해당 제품이 무조건 안전하지 않은 제품이라는 것은 아닙니다. 보건의료업계 종사자와 의료기기 사용자들에게 배포되는 안전성 경고에는 회수(recall)도 포함될 수 있습니다. 제조사가 안전성 경고를 작성하기도 하지만, 보건당국에서 작성하는 경우도 있습니다.

데이터에 대해 더 자세히 알아보기 여기
  • 사례 유형
    Recall / Safety Alert
  • 사례 ID
    31-132-MD/2006-DC (Re. Reg. 2009)
  • 날짜
    2013-12-09
  • 사례 국가
    India
  • 사례 출처
    CDSCO
  • 사례 출처 URL
    https://web.archive.org/web/20180304060129/http://www.cdsco.nic.in/forms/list.aspx?lid=1862&Id=1
  • 비고 / 경고
    The data from India is current through 2017. All of the data comes from the Central Drugs Standard Control Organization, 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 India.
  • 데이터 추가 비고
  • 원인
    Recall of asr hip replacement implants due to increased rates of revision.
  • 조치
    - Do not implant DePuy ASR hip replacements. - Return all unused ASR hip replacement implants to the manufacturer. - Inform all patients implanted with ASR hip replacements about this recall and schedule them for a follow-up visit. - Follow up all patients implanted with ASR hip replacements with clinical examination at least annually. - For patients presenting with symptoms of abnormal pain, limping, swelling around the hip, deteriorating hip function or radiological abnormality: * consider measuring cobalt and chromium ion levels in whole blood and/or performing cross sectional imaging including MRI or ultrasound scan. * If metal ion levels in whole blood are elevated above 120 nmol/L (cobalt) or 135 nmol/L (chromium) [ie seven parts per billion (ppb) for either metal ion], a second test should be performed three months after the first in order to identify patients who require closer surveillance, which may include cross sectional imaging. * If MRI or ultrasound scan reveals soft tissue reactions, fluid collections or tissue masses then consider revision surgery.

Device

ASR XL Acetabular System & DePuy ASR Hip Resurfacing system

Manufacturer

DePuy International Limited