ITOTAL G2
Received Nov 7, 2012 · Event occurred Oct 1, 2012
Report 3004153240-2012-00100 · MDR key 2877477
Device
Product problems
- Device Operates Differently Than Expected
Patient
84 YR
- No Known Impact Or Consequence To Patient
Narrative
Description of Event or Problem
THE LATERAL A TIBIAL POLY INSERT DID NOT LOCK INTO THE TIBIAL TRAY DURING THE PROCEDURE. THE LATERAL B POLY INSERT WAS IMPLANTED SUCCESSFULLY. THE LATERAL B POLY INSERT IS 1MM THICKER THAN THE LATERAL A POLY INSERT.
Additional Manufacturer Narrative
REVIEW OF THE DEVICE HISTORY RECORD INDICATES THAT THE DEVICE WAS MANUFACTURED TO SPECIFICATION. RETURNED DEVICE EVALUATION: THE LATERAL A POLY INSERT WAS RETURNED FOR EVALUATION. PHYSICAL EXAMINATION OF THE RETURNED INSERT SHOWED SIGNIFICANT DAMAGE TO THE SNAP FEATURE OF THE LOCKING MECHANISM. EXAMINATION INDICATES THAT THE POLY INSERT MAY NOT HAVE BEEN ALIGNED PROPERLY AT THE TIME OF IMPACTION DURING THE PROCEDURE. WITH THE INSERT DAMAGED IN THIS MANNER, IT IS LIKELY THAT THE INSERT WAS NOT ABLE TO LOCK INTO THE TRAY.