NEXGEN TM MONOBLOCK LPS TIBIA SIZE: NBR 6

Description of Event or Problem

IT WAS REPORTED THAT THE PATIENT IS EXPERIENCING TWISTING, POPPING AND KNEE GIVING OUT, CAUSING FALLS. THE PATIENT RECEIVED A TM MONOBLOCK LPS TIBIA ON (B)(6) 2011; HOWEVER, IT IS UNKNOWN IF THE PATIENT WAS REVISED. NO FURTHER INFORMATION WAS RECEIVED.

Additional Manufacturer Narrative

THE TM MONOBLOCK TIBIA WAS MANUFACTURED, INSPECTED AND PACKAGED WITHIN ESTABLISHED PROCESS SPECIFICATIONS. THE FEMORAL AND TIBIAL COMPONENTS WERE FOUND TO BE COMPATIBLE. NO X-RAYS, REPORTS OR THE DEVICE ITSELF WERE PROVIDED FOR THIS INVESTIGATION. AS A RESULT, THE CAUSE OF THE ISSUES REPORTED BY THE PATIENT COULD NOT CONCLUDED. THIS INVESTIGATION IS CONSIDERED CLOSED AT THIS TIME; HOWEVER, SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS REPORT SHALL BE UPDATE.

Additional Manufacturer Narrative

INVESTIGATION IS IN PROGRESS.