Events

Safety Alert for Durom Acetabular Component

According to Department of Health, this safety alert involved a device in Hong Kong that was produced by Zimmer.

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
    Safety alert
  • Date
    2012-11-01
  • Event Date Posted
    2012-11-01
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20121101b.html
  • Notes / Alerts
    Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), 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 data from the U.S. and Hong Kong.
  • Extra notes in the data
    Medical Device Safety Alert
  • Reason
    Medical device safety alert: zimmer durom acetabular component the therapeutic goods administration (tga), australia issued a medical device alert concerning durom acetabular component, manufactured by zimmer. the tga advised health professionals and patients that zimmer has cancelled the implant from the australian register of therapeutic goods (artg). the decision to cancel was based on an analysis of data collected by the australian national joint replacement registry (njrr), which revealed that the implant had a higher than expected revision rate. the 2011 njrr report revealed that the durom acetabular component's cumulative revision rate was 9.6% at 7 years in resurfacing applications (compared to 6.1% for all other similar implants) and 6.8% at 5 years in total conventional hip replacements (compared to 3.6% for all other similar implants). for details, please visit the following tga website: http://www.Tga.Gov.Au/safety/alerts-device-hip-dac-121030.Htm if you are in possession of the products, please contact your supplier for necessary actions. posted on 1 november 2012.

Device

Durom Acetabular Component
  • Model / Serial
  • Product Description
    Medical Device Safety Alert: Zimmer Durom Acetabular Component
  • Manufacturer
    Zimmer

Manufacturer

Zimmer
  • Manufacturer Parent Company (2017)
    Zimmer Biomet Holdings
  • Manufacturer comment
    “The safety of patients has always been, and continues to be, Zimmer Biomet’s top priority and it is our honor to be a leader in this industry for the past 90 years,” Zimmer Biomet told ICIJ in a statement. “We adhere to strict regulatory standards, and work closely with the FDA and all applicable regulatory agencies in each of our regions as part of our commitment to operating a first-rate quality management system across our global manufacturing network. The company added that it is focused on staying at the forefront of innovation and doing right by the millions of patients who rely on the company’s products.
  • Source
    DH