balanSys UNI convex PE inlays x/5 - used in knee replacements

Hazard alert - higher than expected rate of PE inlay breakage

9 December 2016

Consumers and health professionals are advised that Mathys Orthopaedics, in consultation with the TGA, has issued a hazard alert for balanSys unicompartmental (UNI) convex polyethylene (PE) inlays with thickness x/5 inlays.

balanSys UNI convex PE inlays are components used in knee replacement procedures.

Affected products are:

  • balanSys UNI convex PE inlay A/5
  • balanSys UNI convex PE inlay B/5
  • balanSys UNI convex PE inlay C/5
  • balanSys UNI convex PE inlay D/5
  • balanSys UNI convex PE inlay E/5

Please note that balanSys UNI convex PE inlays with a thickness of 6, 7 and 9 are not affected by this issue.

It has been identified that the x/5 inlays have a higher than expected rate of breakage. There have been seven reports worldwide of these inlays breaking after approximately five years.

If this occurs, urgent revision surgery is needed to regain knee functionality and to prevent damage to the metal components of the implant.

The observed higher than expected occurrence rate has led to a decision to remove the implant from the market.

Information for consumers

If you or someone you provide care for has had a knee replacement that includes an affected balanSys UNI convex PE inlay, you should be contacted by your orthopaedic surgeon regarding this issue.

If you have any questions or concerns about this issue, contact your orthopaedic surgeon.

Information for health professionals

If you are treating someone who has received an implant using an affected balanSys UNI convex PE inlay, be aware of this issue.

Patients with any knee replacement should be followed up by their orthopaedic surgeon if they have any questions or concerns about their implant.

Information for orthopaedic surgeons

Mathys Orthopaedics has contacted surgeons who have used balanSys UNI convex PE inlays x/5 providing further information about this issue.

If you have implanted this product, you should inform affected patients of this issue and the potential risks. The need for any additional follow-up or possible revision surgery should be determined on a case-by-case basis following a detailed assessment of the patient’s clinical circumstances.

If you have any questions or concerns about this issue, contact Mathys Orthopaedics on 02 9417 9200.

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.