Consumers and health professionals are advised that Zimmer, in consultation with the TGA, is recalling from the market for the purpose of relabelling unused stock of its NexGen micro implants.
Zimmer has also issued a related hazard alert to surgeons.
Once relabelled, the devices will again be available for surgeons.
NexGen micro implants are components of the NexGen Cruciate Retaining (CR) Complete Knee System, used in total knee replacements. In March 2012, Zimmer issued a notification to surgeons following reports of implantation of non-compatible component combinations, even though those combinations were not approved. The notification reminded orthopaedic surgeons to only use compatible component combinations when implanting NexGen CR Complete Knee Systems.
Since then, the implantation of non-compatible component combinations has been monitored.
While occurrences of this issue have been reduced since the 2012 notification, it has not been eliminated, and therefore Zimmer is recalling the above NexGen micro implants to relabel the implants to further reinforce the importance of using correct component combinations.
Information for consumers
Zimmer has written to surgeons who have implanted NexGen CR Complete Knee Systems, providing further information about the above issue.
If you have had a knee replacement and experience long-term pain, instability and/or decreased range of motion, or if you have any questions or concerns, contact your surgeon or the hospital where the surgery was undertaken.
Information for all health professionals
Patients who have had a knee replacement and who have any questions or concerns about the above issue should be referred to their surgeon or the hospital where the surgery was undertaken.
Information for orthopaedic surgeons
Zimmer has written to surgeons who have implanted NexGen CR Complete Knee Systems, providing further information about the above issue.
Surgeons and hospitals should check to see if they have any unused NexGen micro implants in stock. If so, follow the instructions outlined in the recall letter from the sponsor.
For patients who have already had a NexGen CR Complete Knee System implanted using NexGen micro components, surgeons should consider each patient’s individual circumstances when deciding whether examination and radiographic review is necessary before their next normal post-operative follow-up appointment. Otherwise, affected patients should be followed up in accordance with routine protocols and monitored for any symptoms that may be related to this issue.
Additional information
The non-compatible component combinations include:
- CR micro articular surface with CR standard femur
- CR micro femur with CR standard articular surface
- micro patella with standard femur
- CR micro femur with standard patella.
Using a non-compatible CR articular surface and CR femur may result in:
- immediate risk that the knee cannot be properly balanced, potentially leading to long-term pain and instability
- long-term risk of increased wear of the polyethylene, which may lead to pain, osteolysis, tibial loosening, instability and revision surgery - this risk is greater if a CR micro articular surface is implanted with a CR standard femur, compared with a CR standard articular surface being implanted with a CR micro femur.
Using a non-compatible patella and femur may result in:
- immediate risk that proper patella tracking cannot be achieved, leading to long-term pain and instability
- long-term risk of decreased range of motion, as well as increased wear of the polyethylene, which may lead to pain, osteolysis, implant loosening, patella fracture and revision surgery - the risk of increased wear is greater if a micro patella is implanted with a CR standard femur, compared with a standard patella being implanted with a CR micro femur.
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.