| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2014-RN-00698-1 |
| Product Name/Description |
NexGen Complete Knee Solution MIS Total Knee Procedure Stemmed Tibial Component, Precoat
Various sizes
ARTG Number: 96761 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
7/07/2014 |
| Responsible Entity |
|
| Reason/Issue |
Zimmer is initiating a Hazard Alert for specific lots already implanted due to the potential that the threads may be out of specification. Zimmer received twelve complaints over a period of two and a half years alleging difficulty threading an MIS Drop Down Stem Extension or a Drop Down Stem Plug into the MIS Stemmed Tibial Component. There were no complaints received from Australia. The potential risks for this issue are:
· Additional bone loss may occur if the MIS tibial is cemented in place when the issue is identified and the surgeon elects to remove and replace.
· Early revision may occur due to loosening (if the MIS Stemmed Tibial Component is implanted without a drop down stem extension), and/or infection.
· Disassociation of the implanted articular surface may occur if the stem extension does not fully seat, thus causing the articular surface to not properly lock. |
| Recall Action |
Hazard Alert |
| Recall Action Instructions |
Zimmer is providing surgeons with details of the potential risks associated with out of specification thread. For patients implanted with a potentially affected device, Zimmer recommends continued normal post-operative follow-up. For more details, please see http://www.tga.gov.au/safety/alerts-device-nexgen-complete-knee-solution-140709.htm . |
| Contact Information |
1800 803 263 - Zimmer Customer Service |