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