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