Events

Device Recall DEPUY ASR XL ACETABULAR CUP SYSTEM 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Depuy Orthopaedics, Inc. 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
    57177
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1807-2011
  • 사례 시작날짜
    2010-08-23
  • 사례 출판 날짜
    2011-03-24
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2013-08-29
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=96137
  • 비고 / 경고
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • 데이터 추가 비고
    Prothesis, hip, semi-constrained (metal uncemented acetabular component - Product Code KWA
  • 원인
    As part of our ongoing post-market surveillance of all products, depuy is continually evaluating data from a variety of sources including national joint replacement registries, published literature, company sponsored clinical trials, internal complaints data and unpublished clinical research reports. depuy orthopaedics issued a field safety notice in march 2010 after receiving new data from the.
  • 조치
    DePuy Orthopaedics issued a Field Safety Notice in March 2010 to all affected customers. The Notice identified the product, the problem, and the action to be taken by the customer. Customers were instructed to share the Field Safety Notice with their organization and any organization where the ASR products may have been transferred. Customer were instructed not to implant the ASR devices. Patients who received the ASR System should be informed of this recall and instructed to return for a follow up visit. Patients with radiographic changes indicative of product failure should be addressed according to normal procedures. All other patients should be followed according to the April 22, 2010, and May 25, 2010 UK Medicines and Healthcare products Regulatory Agency (MHRA) Device Alerts. Follow up for all patients implanted with ASR acetabular cups at least annually for five years postoperatively. Beyond five years, follow up in accordance with locally agreed protocols. For patients who are symptomatic or implanted with a cup angle greater than 45 degrees, particulary where a small component has been implanted.: " Consider measuring cobalt and chromium ion levels in whle blood and/or performing cross sectional imaging including MRI or ultrasound scans. " If metal ion levels in whole blood are elevated above 7 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 revision surgery should be considered. DePuy representatives were to assist with returns of any remaining inventory. For questions regarding this recall call 574-372-7333.

Device

Device Recall DEPUY ASR XL ACETABULAR CUP SYSTEM
  • 모델명 / 제조번호(시리얼번호)
    Part Number 999830768, Size 68, All lots.
  • 의료기기 분류등급
    Orthopedic Devices
  • 의료기기 등급
    3
  • 이식된 장치?
    Yes
  • 유통
    Worldwide
  • 제품 설명
    ASR 300 Size 68, DEPUY ASR XL ACETABULAR CUP SYSTEM. || The DePuy ASR XL Acetabular Cup components are part of a modular system designed to replace the natural articular surface of the hip joint in total hip replacement. The acetabular cup is designed as a cobalt-chrome-molybdenum (CoCrMo) alloy one piece cup with a porous coating and is available in outer diameter sizes 64mm through 70mm in two-millimeter increments. The outer surface of the cup has a porous coating with the addition of a hydroxyapatite (HA) coating. There are no separate liner components to this system, as the liners are integral to the one-piece acetabular cups. || Two cup configurations will be offered: a "spiked" cup with three fixation spikes on the outer surface of the cup for adjunct fixation, and an acetabular cup with no spikes. Both configurations are specific to the DePuy ASRTM Cup System cleared in K040627 and K073413. This submission is a line extension of the acetabular cup components. These acetabular cups will be compatible with DePuy ASRTM femoral components. || The uni femoral head is manufactured from cobalt-chrome-molybdenum (CoCrMo) alloy and is available in a range of diameters from 57mm to 63mm in two-millimeter increments. The uni femoral heads have an internal taper which mates with a taper sleeve adapter specific to DePuy 12/14 or 11/13 tapers. The femoral heads articulate with corresponding one-piece metal acetabular cups. || The subject heads use taper sleeve adapters to mate the DePuy femoral heads to DePuy femoral stems and are manufactured from cobalt-chrome-molybdenum (CoCrMo) alloy. || Prescription Use, Sterile || The device is part of a modular system for use in total hip replacement in which the acetabular component articulates with a femoral component. The DePuy ASR XL Acetabular Cup System is compatible with DePuy ASRT femoral components. The device is indicated for use in the following conditions, where there is evidence of sufficient sound bone to seat and support the components: 1. A severely painful and/or disabled joint from osteoarthritis, traumatic arthritis, rheumatoid arthritis, or congenital hip dysplasia. 2. Avascular necrosis of the femoral head. 3. Acute traumatic fracture of the femoral head and neck. 4. Failed previous hip surgery, including internal fixation, arthrodesis and hemiarthroplasty. 5. Certain cases of ankylosis. Porous-coated DePuy ASR MXL Acetabular Cups are indicated for cementless application.
  • Manufacturer
    Depuy Orthopaedics, Inc.

Manufacturer

Depuy Orthopaedics, Inc.
  • 제조사 주소
    Depuy Orthopaedics, Inc., 700 Orthopaedic Dr, Warsaw IN 46582-3994
  • Source
    USFDA