PLEXUR M

Description of Event or Problem

IT WAS REPORTED THAT A PT RECEIVED RESORBABLE BONE VOID FILLER IN THE TIBIAL CONDYLE DURING A KNEE REVISION CASE, AND SUBSEQUENTLY DEVELOPED A POST-OP INFECTION. THE SURGEON 'WENT BACK IN" AFTER 7 MONTHS AND REPORTED THAT THE PRODUCT WAS "GOO". THE SURGEON REPORTEDLY STATED HE DID NOT FEEL THE GRAFT MATERIAL CAUSED OR CONTRIBUTED TO THE INFECTION. NO ADD'L PT OR DEVICE INFO WAS PROVIDED.

Additional Manufacturer Narrative

THIS MEDWATCH REPORT WAS COMPLETED USING THE INFO PROVIDED BY THE INITIAL REPORTED/HEALTHCARE PROFESSIONAL. ANY MISSING OR INCOMPLETE DATA IS THE RESULT OF THE INFO NOT HAVING BEEN PROVIDED. WITHOUT ADD'L PT OR DEVICE INFO, NO REVIEW OF THE MFG RECORDS IS POSSIBLE, AND WE ARE UNABLE TO DETERMINE THE DEFINITIVE CAUSE OF THE REPORTED EVENT. THE SUBJECT PRODUCT IS TERMINALLY STERILIZED WITH GAMMA IRRADIATION PRIOR TO DISTRIBUTION. THE PRODUCT IS MANUFACTURED USING RESORBABLE POLYMERS AND IS NOT INTENDED TO PROVIDE STRUCTURAL SUPPORT DURING THE HEALING PROCESS.