| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2012-RN-01012-1 |
| Product Name/Description |
Apex K2 Modular Hip Replacement System (total joint prosthesis)
Multiple Catalogue Numbers
Previous ARTG Number: 149020 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
18/10/2012 |
| Responsible Entity |
|
| Reason/Issue |
The annual reports of the Australian National Joint Registry [NJRR], have indicated a higher than expected revision rate for this prosthesis since 2010. The 2011 NJRR report indicated that the cumulative revision rate for the Device was 5.2% at 1 year from the time of implantation, and a headline revision rate of 4.6 revisions per 100 observed years. The revision rate for the implant continues to be higher than that of similar implants being used in Australia. The Apex K2 Stem has not been available for implantation since early October 2011.This device has now also been cancelled from the Australian Register of Therapeutic Goods as well as the Private Hospital Prosthesis List. |
| Recall Action |
Hazard Alert |
| Recall Action Instructions |
Global Orthopaedic Technology is advising implanting/treating surgeons on how to manage patients implanted with Apex K2 Femoral Stem. For more details, please see http://www.tga.gov.au/safety/alerts-device-hip-apex-k2-121030.htm |
| Contact Information |
02 8887 0164 - Global Orthopaedic Technology Regulatory Affairs Manager |