Events

Recall Or Safety Alert for ASR XL Acetabular System & DePuy ASR Hip Resurfacing system

According to Central Drugs Standard Control Organization, this recall or safety alert involved a device in India that was produced by DePuy International Limited.

What is this?

Alerts provide important information and recommendations about products. Even though an alert has been issued, it does not necessarily mean a product is considered to be unsafe. Safety Alerts, addressed to health workers and users, may include recalls. They can be written by manufacturers, but also by health officials.

Learn more about the data here
  • Type of Event
    Recall / Safety Alert
  • Event ID
    31-132-MD/2006-DC (Re. Reg. 2009)
  • Date
    2013-12-09
  • Event Country
    India
  • Event Source
    CDSCO
  • Event Source URL
    https://web.archive.org/web/20180304060129/http://www.cdsco.nic.in/forms/list.aspx?lid=1862&Id=1
  • Notes / Alerts
    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.
  • Extra notes in the data
  • Reason
    Recall of asr hip replacement implants due to increased rates of revision.
  • Action
    - 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