| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2012-RN-00988-1 |
| Product Name/Description |
Birmingham Hip Modular Head (Used as part of a Total Conventional Hip Replacement system)
Part Numbers : 121238 – 121258, 121338 – 121558, 74121238 – 74121558 & 74222138 – 74222162
All Batches
ARTG Number: 124100 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
2/10/2012 |
| Responsible Entity |
|
| Reason/Issue |
The Birmingham HipTM Modular Head (BHMH) as part of a Total Conventional Hip Replacement system has been identified in the Australian National Joint Replacement Registry (NJRR) and the National Joint Registry of England and Wales (NJREW) as having a higher than expected revision rate when compared to all other total conventional hip replacements. In addition, most of the revisions that are occurring later (after the third year) are linked to metal sensitivity and infection. |
| Recall Action |
Hazard Alert |
| Recall Action Instructions |
Smith & Nephew is advising implanting/treating surgeons on how to manage patients implanted with the Birmingham Hip Modular Heads. For more information, please see http://www.tga.gov.au/safety/alerts-device-hip-bhmh-121030.htm |
| Contact Information |
02 9857 3917 - Smith & Nephew |