E-POLY 40MM +3 MAXROM LNR SZ25

Additional Manufacturer Narrative

(B)(4). CONCOMITANT MEDICAL PRODUCTS: TPRLC XR T1 PPS 18X156MM, (B)(4), LN 2866723; SELEX/MAGNUM MOD HD 40MM +6, PN (B)(4), LN 527450; M/H RADIAL SOLID/APX SHL 58MM, PN (B)(4), LN 815950. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT. PLEASE SEE REPORTS: 0001825034-2018-06485, 0001825034-2018-06486, 0001825034-2018-06489. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS; HOWEVER, AN INVESTIGATION OF THE REPORTED EVENT IS IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETED, A SUPPLEMENTAL MDR WILL BE SUBMITTED.

Description of Event or Problem

IT WAS REPORTED THAT PATIENT UNDERWENT A REVISION PROCEDURE DUE TO FEMORAL SUBSIDENCE AND INFECTION APPROXIMATELY SEVEN MONTHS POST-IMPLANTATION. ALL COMPONENTS WERE REVISED. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

Additional Manufacturer Narrative

(B)(4). REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. DHR WAS REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT WERE FOUND. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED WITH THE INFORMATION PROVIDED. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.