Zimmer Biomet Trabecular Metal knee implant components

Hazard alert - potential for post-operative infection

26 May 2016

Consumers and health professionals are advised that Zimmer Biomet, in consultation with the TGA, has issued a hazard alert for specific lots of Trabecular Metal knee implant components.

Trabecular Metal knee implant components are used in knee replacement surgery.

It has been identified that there is potential for tears/holes to develop in the packaging containing the implant components. 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).

The implants are supplied in foil pouches, part of a dual-barrier system to provide sterile integrity. Testing by Zimmer Biomet found that in some instances tears/holes in some of the foil pouches were present in either the inner foil pouch or the outer foil pouch, but never both in the same sample.

Tear/hole in the inner or outer foil pouch
Tear/hole in the inner or outer foil pouch

Potentially affected implants were distributed between April 2011 and March 2016.

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 damage is visible. 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 manifest within 12 months of the device being implanted.

Please note that there is potential for fever after any invasive surgery. Therefore, if a patient who has a Zimmer Biomet Trabecular Metal knee implant component experiences a post-operative infection, it does not necessarily mean they have received a non-sterile implant.

Information for consumers

The surgical and infection control procedures, applied during knee replacements involving Zimmer Biomet Trabecular Metal knee implant components, make an infection unlikely.

Should an infection develop as a result of a non-sterile implant, this would 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 the surgical and infection control procedures, applied during knee replacements involving Zimmer Biomet Trabecular Metal knee implant components, make an infection unlikely.

Advise them that the risk of developing an infection as a result of receiving a non-sterile implant is only present 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

Zimmer Biomet has contacted surgeons who have implanted Zimmer Biomet Trabecular Metal knee implant components informing them of the above issue, including the affected lot numbers, and advising them to follow normal post-operative treatment for potentially affected patients.

If you have any questions or concerns about this issue, contact Zimmer Biomet on 02 9483 5426.

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.