MalfunctionHSH
NEXGEN STEMMED TIBIAL COMPONENT
Received Nov 24, 2010 · Event occurred Jun 20, 2010
Report 1822565-2010-01202 · MDR key 1934610
Device
Product problems
- Loose
Patient
61 YR
- Pain
Narrative
Description of Event or Problem
IT IS REPORTED THAT THE PT'S KNEE CLICKS AND THAT REVISION IS PENDING FOR TIBIA LOOSENING.
Additional Manufacturer Narrative
INFO WAS RECEIVED FROM A CONSUMER WHO IS NOT REQUIRED TO COMPLETE FORM 3500A. THIS REPORT WILL BE AMENDED WHEN OUR INVESTIGATION IS COMPLETE.