Events

ADVANCE HA Coated Titanium Tibial Bases, all sizes 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Surgical Specialties 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-00883-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2016-11-16
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-00883-1
  • 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
    In october 2015, the aoajnrr annual report indicated that the implant was experiencing higher than expected revision rates of 1.37 revisions per 100 observed years. the cumulative percent revision of the implant at 10 years is 11.8% compared to 5.5% for other knee implants. further analysis showed that a large proportion of the revisions (46.9% of revisions, 2.3% of primary procedures) were due to loosening/lysis, and that the advance ha coated tibial base was contributing to the higher rate and therefore microport has decided to remove this device from the market. advance ha coated tibial bases have not been used in australia since 2013 and have been withdrawn from the australian register of therapeutic goods (artg).
  • 조치
    MicroPort Orthopaedics Pty Ltd is contacting surgeons to make them aware of this issue with the advice that the likelihood of a patient experiencing a postoperative loosening is very low. Should a patient experience sudden pain, instability, difficulty walking and/or performing common tasks, a tibial loosening can be confirmed via x-ray. A loosened tibial base may require removal through revision surgery. For more details, please see https://www.tga.gov.au/alert/advance-ha-coated-tibial-bases . This action has been closed-out on 24/05/2017.

Device

ADVANCE HA Coated Titanium Tibial Bases, all sizes
  • 모델명 / 제조번호(시리얼번호)
    ADVANCE HA Coated TitaniumTibial Bases, all sizesPart Numbers: KTTIHA10, KTTIHA11, KTTIHA20, KTTIHA21, KTTIHA30, KTTIHA31, KTTIHA40, KTTIHA41, KTTIHA50, KTTIHA51, KTTIHA60All Lots
  • Manufacturer
    Surgical Specialties Pty Ltd

Manufacturer

Surgical Specialties Pty Ltd