Persona Trabecular Metal tibial plate (used in knee replacements)
Hazard alert due to potential for implant failure due to loosening.
Consumers and health professionals are advised that Zimmer, in consultation with the TGA, has issued a hazard alert for Persona Trabecular Metal tibial plates (all sizes).
Persona Trabecular Metal tibial plates are a component used in total knee replacements. They can be implanted using bone cement for the fixation of the device, or without cement (cementless).
It has been identified that there is a higher than expected rate of complaints for loosening of these devices.
If an implant does not have appropriate fixation, it can lead to the patient experiencing pain or, in the longer term, the need for revision surgery.
Persona Trabecular Metal tibial plates have been distributed in Australia since 2014.
As of 16 March 2015, there have been 40 complaints worldwide of loosening involving Persona Trabecular Metal tibial plates, of which 16 indicated that revision surgery was performed. Loosening of cementless components is the most common cause for revision of knee replacements using these devices.
As of 16 March 2015, there have been no complaints of loosening involving Persona Trabecular Metal tibial plates or revisions for these devices in Australia.
Information for consumers
Zimmer has written to orthopaedic surgeons who have implanted Persona Trabecular Metal tibial plates providing further information and advice regarding follow-up for affected patients.
If you or someone you care for has had a knee replacement using a Persona Trabecular Metal tibial plate 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
Zimmer has written to orthopaedic surgeons who have implanted Persona Trabecular Metal tibial plates providing further information and advice regarding follow-up for affected patients.
If you are treating patients who have had a knee replacement using a Persona Trabecular Metal tibial plate and they are experiencing unexpected pain and/or knee instability, or continue to have questions or concerns about this issue, refer them to their surgeon or the hospital where the surgery was undertaken.
Information for orthopaedic surgeons
Zimmer has written to orthopaedic surgeons who have implanted Persona Trabecular Metal tibial plates advising them to follow-up with affected patients and otherwise continue the normal post-operative follow-up routine.
The current complaint rate for these devices is 0.61% for radiolucent lines and loosening. Of the complaints received, 36% identified symptomatic radiolucent lines or were revised for loosening, while 28% identified asymptomatic radiolucencies, 8% subsided and 28% were inconclusive.
If you have any questions or concerns relating to this issue, contact Zimmer by phone on 02 9483 5400.
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.