| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2014-RN-00685-1 |
| Product Name/Description |
MSA Hip System
MSA Neutral Femoral Neck
Catalogue number range: GH-220-00 to GH-260-08
MSA Ante-Retro-Version Femoral Neck
Catalogue number range: GH-221-00 to GH-261-00
MSA Titanium HA Custom Femoral Stem
Catalogue number range: GH-1400-00 to GH-14000-25
ARTG Number: 120787 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
30/06/2014 |
| Responsible Entity |
|
| Reason/Issue |
The 2013 annual report of the National Joint Replacement Registry (NJRR) indicates that up to December 2012, the cumulative percent revision of the MSA Hip System has been calculated as 6.2 % at one year and approximately 11% at 2 years , both of which are significantly higher than that of other hip replacement prostheses. The most common reasons for revision of MSA to date have been loosening/lysis and peri-prosthetic fracture, but there have also been a few revisions due to prosthesis dislocation, pain and infection.
After consultation with the Therapeutic Goods Administration, a decision has been made by Global Orthopaedic Technology to cease supply of the MSA Hip Stem. This device has been removed from the Australian Register of Therapeutic Goods. |
| Recall Action |
Hazard Alert |
| Recall Action Instructions |
Global Orthopaedic Technology is informing implanting surgeons that it is advisable for annual clinical and radiological examinations to be performed on patients who have been implanted with this device, in accordance with routine patient post arthroplasty care. For more details, please see http://tga.gov.au/safety/alerts-device-msa-hip-system-140703.htm . |
| Contact Information |
1800 456 225 - Global Orthopaedic Technology Customer Service |