Events

Safety Alert for Apex K2 Femoral Stem

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

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_20121101a.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: omnilife science apex k2 femoral stem the therapeutic goods administration (tga), australia issued a medical device alert concerning apex k2 femoral stem, manufactured by omnilife science, inc. (global orthopaedic technology as the sponsor in australia) the tga advised health professionals and patients that global orthopaedic technology has cancelled the apex k2 femoral stem from the australian register of therapeutic goods. the decision to cancel was based on an analysis of data collected by the australian national joint replacement registry (njrr), which revealed that the apex k2 femoral stem had a higher than expected revision rate. the 2012 australian njrr report indicated that the cumulative revision rate for the apex k2 modular hip replacement system was 5.5% at 1 year from the time of implantation and 9.3% at 3 years. a headline revision rate of 4.6 revisions per 100 observed years compared to 1.6% at 1 year and 2.8 % at 3 years from implantation and a headline revision rate of 0.81 revisions per 100 observed years for all other total conventional hip replacements. for details, please visit the following tga website: http://www.Tga.Gov.Au/safety/alerts-device-hip-apex-k2-121030.Htm if you are in possession of the products, please contact your supplier for necessary actions. posted on 1 november 2012.

Device

Apex K2 Femoral Stem
  • Model / Serial
  • Product Description
    Medical Device Safety Alert: OMNILife science Apex K2 Femoral Stem
  • Manufacturer
    OMNILife science

Manufacturer

OMNILife science