InjuryHSH
ITOTAL
Received Nov 16, 2012 · Event occurred Oct 1, 2012
Report 3004153240-2012-00108 · MDR key 2839207
Device
Product problems
- Adverse Event Without Identified Device or Use Problem
Patient
63 YR
- No Known Impact Or Consequence To Patient
Narrative
Description of Event or Problem
A REVISION SURGERY PLANNED TO EXCHANGE POLY INSERT FOR PATIENT WITH A TOTAL KNEE IMPLANT.
Additional Manufacturer Narrative
REVISION SURGERY PLANNED TO EXCHANGE POLY INSERT FOR PATIENT WITH A TOTAL KNEE IMPLANT. REVIEW OF THE DEVICE HISTORY RECORD INDICATES THAT THE DEVICE WAS MANUFACTURED TO SPECIFICATION.