Duracon augments tibial wedge implants - used in knee replacements

Hazard alert - potential for post-operative infection

12 October 2015

Consumers and health professionals are advised that Stryker Australia, in consultation with the TGA, has issued a hazard alert for specific lots of Duracon augments tibial wedge implants.

Duracon augments tibial wedge implants are components used in knee replacement surgery (see image below). They replace bone or provide additional build-up to address certain problems, typically as part of revision surgery.

Duracon tibial wedge implant

It has been identified that there is potential for Duracon augments tibial wedge implants to puncture the packaging before use. If this happens and is not detected in the operating room before implantation, the patient may receive a non-sterile implant and consequently suffer a post-operative infection (for example a fever).

There have been two overseas reports in which this device punctured the packaging before use, but in both cases the issue was recognised in the operating room and another implant was used.

The Instructions for Use (IFU) for these implants require that operating room staff inspect the package for damage before implantation and to not use the implant if any is identified. Due to this, it is unlikely that a patient would receive a non-sterile implant because of this issue. If a post-operative infection did occur, it would typically be in the period immediately following surgery.

Please note that there is potential for fever after any invasive surgery. Therefore, if a patient who receives Duracon augments tibial wedge implants experiences a post-operative infection, it does not necessarily mean they have received a non-sterile implant.

Information for consumers

The surgical procedures used for Duracon augments tibial wedge implants mean that, even if these components were used in knee replacement surgery, the likelihood of the above issue occurring is low.

The risk of developing a fever as a result of receiving a non-sterile implant is only present immediately after the surgery.

If you or someone you care for has recently had knee replacement surgery and you have any questions or concerns about this issue, please contact your surgeon or the hospital where the surgery was undertaken.

Information for all health professionals

If you are treating a patient who has recently had knee replacement surgery, reassure them that surgical procedures used for Duracon augments tibial wedge implants mean that the likelihood of the above issue occurring is low.

Advise them that the risk of developing an infection as a result of receiving a non-sterile implant is only presently immediately after surgery.

If they continue to have questions or concerns about this issue, refer them to their surgeon or the hospital where the surgery was undertaken.

Information for surgeons

Stryker Australia has contacted surgeons who have implanted Duracon augments tibial wedge implants informing them of the above issue, including the affected lot numbers, and advising them to follow normal post-operative treatment for potentially affected patients.

According to Stryker Australia's records, all potentially affected products have been used (contact Stryker Australia on 1800 803 601 if you require further details of the affected lots).

If you have any questions or concerns about this issue, contact Stryker Australia on 1800 803 601.

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.