Consumers and health professionals are advised that Global Orthopaedic Technology, in consultation with the TGA, is issuing a hazard alert for the MSA Hip System due to it having a higher than expected revision rate. Global Orthopaedic Technology has ceased supply of the system and it has been removed from the Australian Register of Therapeutic Goods.
The MSA Hip System is a modular hip replacement system, which includes a short femoral stem which connects with a femoral neck (either an MSA Neutral Femoral Neck or an MSA Ante-Retro-Version Femoral Neck). These components are used with a number of different modular femoral head and acetabular components in total hip replacement procedures.
The femoral stem component of the MSA Hip System was identified in the 2013 annual report of Australian Orthopaedic Association's National Joint Replacement Registry (AOANJRR) as having a higher than expected revision rate. To December 2012, the cumulative percent revision rate for the MSA Hip System was 6.2% at one year and approximately 11% at two years, both of which were significantly higher compared to other total hip replacement prostheses used in Australia.
Based on its own post-market surveillance program, Global Orthopaedic Technology had previously decided to limit supply of the MSA Hip System to specially trained orthopaedic surgeons. However, after the AOANJRR and the TGA identified that the MSA implant had a higher than expected revision rate, Global Orthopaedic Technology decided to remove the MSA Hip System from sale.
Information for consumers
Global Orthopaedic Technology has written to orthopaedic surgeons who have implanted the MSA Hip System, providing further information about the above issue.
If you have any questions or concerns, please contact your surgeon or the hospital where the surgery was undertaken.
Information for all health professionals
If you are treating patients who have had a hip replacement and are concerned about the above issue, reassure them that the likelihood of them experiencing related problems is very low.
Patients who continue to have questions or concerns about this issue should be referred to their orthopaedic surgeon or the hospital where the surgery was undertaken.
Information for orthopaedic surgeons
Global Orthopaedic Technology has written to orthopaedic surgeons who have implanted the MSA Hip System, providing further information about the above issue.
In particular, implanting surgeons are advised to schedule annual clinical and radiological examinations for patients who have been implanted with this device, in accordance with routine patient post-arthroplasty care.
The most common reasons for revision of the MSA Hip System 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.
If you have any questions or concerns about this issue, contact Global Orthopaedic Technology on 1800 456 225.
Reporting problems
Consumers and health professionals are encouraged to report problems with medical devices. Your report will contribute to the TGA's monitoring of these products. For more information see the TGA Incident Reporting and Investigation Scheme (IRIS).
The TGA cannot give advice about an individual's medical condition. You are strongly encouraged to talk with a health professional if you are concerned about a possible adverse event associated with a medical device.