InjuryHSH
ITOTAL
Received Oct 3, 2012 · Event occurred Sep 1, 2012
Report 3004153240-2012-00084 · MDR key 2782090
Device
Product problems
- Device Operates Differently Than Expected
Patient
53 YR
- Post Operative Wound Infection
Narrative
Description of Event or Problem
PATIENT WITH A TOTAL KNEE IMPLANT DEVELOPED AN INFECTION. REVISION SURGERY IS PLANNED.
Additional Manufacturer Narrative
PATIENT WITH A TOTAL KNEE IMPLANT DEVELOPED AN INFECTION. REVISION SURGERY IS PLANNED. REVIEW OF THE DEVICE HISTORY RECORD INDICATES THAT THE DEVICE WAS MANUFACTURED TO SPECIFICATION. ALL STERILIZATION REQUIREMENTS WERE MET.