Consumers and health professionals are advised that Smith & Nephew Surgical, in consultation with the TGA, has issued a hazard alert for Genesis II Knee System - non-porous tibial baseplates model number 71420182 with batch number 14CT39993.
The Genesis II Knee System - non-porous tibial baseplate is a component used in total knee replacements.
It has been identified that the surfaces of the identified batch of baseplates do not meet the product's specifications. Specifically, part of the device has been found to have inadequate surface roughness. This could result in poor fixation and loosening of the baseplate, which may lead to the device failing and the need for revision surgery. However, an analysis conducted by the manufacturer has found that the health risk for patients who have an affected device is low.
Only 18 affected devices have been implanted in Australia between May and September 2014.
This issue was discovered during the manufacturer's quality assurance processes. As of 20 February 2015, no adverse events associated with this issue have been reported in Australia or overseas.
Information for consumers
Smith & Nephew Surgical has written to orthopaedic surgeons who have implanted the affected devices providing further information and advice regarding follow-up monitoring.
Surgeons have been advised to discuss this issue, including potential symptoms (particularly pain and knee instability), with affected patients. As of 20 February 2015, there have been no reports of associated adverse events in Australia or overseas.
If you or someone you care for has had a knee replacement using a Genesis II Knee System (implanted between May and September 2014) and you have any questions or concerns about this issue, contact your surgeon or the hospital where the surgery was undertaken.
Information for all health professionals
Smith & Nephew Surgical has written to orthopaedic surgeons who have implanted the affected devices providing further information and advice regarding follow-up monitoring.
Surgeons have been advised to discuss this issue, including potential symptoms (particularly pain and knee instability), with affected patients. As of 20 February 2015, there have been no reports of associated adverse events in Australia or overseas.
If you or someone you care for has had a knee replacement using a Genesis II Knee System (implanted between May and September 2014) and you have any questions or concerns about this issue, contact your surgeon or the hospital where the surgery was undertaken.
Information for all health professionals
Smith & Nephew Surgical has written to orthopaedic surgeons who have implanted affected device providing further information and advice regarding follow-up monitoring.
If you are treating patients who have had a knee replacement and are concerned about the above issue, reassure them that the number of affected devices implanted in Australia is low and surgeons have been advised to discuss this issue, including potential symptoms (particularly pain and knee instability), with affected patients.
If patients continue to have questions or concerns, refer them to their surgeon or the hospital where the surgery was undertaken.
Information for orthopaedic surgeons
Smith & Nephew Surgical has written to orthopaedic surgeons who have implanted affected devices (model number 71420182 with batch number 14CT39993), advising them to:
- follow standard post-operative follow-up protocols and actions for their patients
- ensure that patients are informed about symptoms (particularly unexpected pain and knee instability) that could indicate the need for implant review or revision surgery, and the need to seek follow-up care if these symptoms arise.
If you have any questions or concerns relating to this issue, contact Smith & Nephew Surgical by phone on 02 9857 9308.
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.