Consumers and health professionals are advised that Zimmer Biomet, in consultation with the TGA, is issuing an Implant Hazard Alert for the NexGen Stemmed Cemented Option Tibial Component.
The NexGen Stemmed Cemented Option Tibial Component is a component used in some total knee replacements (TKR).
There is a clinically important higher overall revision rate and increased revision rate for aseptic tibial loosening when these tibial components are used with either the Legacy Posterior Stabilized (LPS) Flex or LPS Flex Gender Solutions Femoral (GSF) Components. This information is in the recently published 19th Annual Report from the United Kingdom National Joint Registry (NJR).
Tibial loosening would typically present as new pain in the knee joint.
Affected devices
Only the NexGen Stemmed Cemented Option tibial component when used in combination with
- the LPS Flex (non-porous) or
- the LPS Flex GSF (non-porous)
have the higher revision rates.
Non-affected devices
The NexGen Stemmed Cemented Option tibial component when used with the following femoral components are not affected:
- LPS non-porous
- CR porous
- CR non-porous
- CR flex porous
- CR flex non-porous
- CR Flex GSF porous
- CR Flex GSF non-porous
Information for patients
Even if you have a knee component within the scope of this implant hazard alert, it does not necessarily mean that the knee component is not functioning well or needs to be replaced.
If you have been experiencing any new pain, inability to bear weight, swelling or instability of the knee, it is recommended that you follow-up with your surgeon or another health care provider for further investigation of the cause of the pain.
Information for all health professionals
If you are treating patients who have had this replacement and are concerned about this issue, advise them to discuss it with their orthopaedic surgeon at the next consultation.
Information for orthopaedic surgeons
Zimmer Biomet has written to all orthopaedic surgeons who have implanted the NexGen System with this combination, providing further information.
Zimmer Biomet has recommended that surgeons should have additional clinical and/or radiographic follow-up with patients implanted with this combination who are experiencing any new pain, inability to bear weight, swelling or instability of the knee to ensure it is not due to tibial loosening.
Removal of any knee arthroplasty when a patient is not experiencing any symptoms is not recommended.
List of products affected
| Item Number | Device Identifier | Tibial Component Description |
|---|---|---|
| 00-5986-037-01 | 00889024218833 | NexGen Complete Knee Solution - Stemmed Nonaugmentable Tibial Component, Option Size 3 |
| 00-5986-037-02 | 00889024218840 | NexGen Complete Knee Solution - Stemmed Nonaugmentable Tibial Component, Option, Size 4 |
| 00-5986-047-01 | 00889024218857 | NexGen Complete Knee Solution - Stemmed Nonaugmentable Tibial Component, Option, Size 5 |
| 00-5986-047-02 | 00889024218864 | NexGen Complete Knee Solution - Stemmed Nonaugmentable Tibial Component, Option, Size 6 |
| 00-5986-057-01 | 00889024218871 | NexGen Complete Knee Solution - Stemmed Nonaugmentable Tibial Component, Option, Size 7 |
| 00-5986-057-02 | 00889024218888 | NexGen Complete Knee Solution - Stemmed Nonaugmentable Tibial Component, Option, Size 8 |
For further information contact Zimmer Biomet Customer Service Team at 02 9483 5400 or email Recall.ANZ@zimmerbiomet.com
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.