BIOMET ILOK PRI TIB TRAY 79MM

Description of Event or Problem

IT WAS REPORTED THAT PATIENT UNDERWENT A LEFT KNEE REVISION APPROXIMATELY EIGHTEEN (18) YEARS POST-IMPLANTATION DUE TO TIBIAL INSERT WEAR AND BLACK SYNOVIAL TISSUE. THE TIBIAL INSERT WAS REMOVED AND REPLACED.

Additional Manufacturer Narrative

(B)(4). D10 MEDICAL DEVICES: MAXIM PRI DCM TIB BRNG10X79/83MM CATALOG#: 11-146170 LOT#: 751950. MAXIM ILOK ANA PRI FEMORAL 70 LT CATALOG#: 140033 LOT#: 900010. BIOMET FINNED PRI STEM 40MM CATALOG#: 141314 LOT#: 775900. BMET ARCOM AP PAT W/WIRE 37MM CATALOG#: 11-150830 LOT#: 753510. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, AS IT REMAINS IMPLANTED. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

Description of Event or Problem

IT WAS REPORTED THAT PATIENT UNDERWENT A RIGHT KNEE REVISION APPROXIMATELY EIGHTEEN (18) YEARS POST-IMPLANTATION DUE TO TIBIAL INSERT WEAR AND BLACK SYNOVIAL TISSUE. THE TIBIAL INSERT WAS REMOVED AND REPLACED.

Additional Manufacturer Narrative

THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. UPDATED: B4, B5, G3, G6, H2, H3, H6, H10, AND H11. REPORTED EVENT WAS CONFIRMED BY REVIEW OF MEDICAL RECORDS. RADIOGRAPHS WERE PROVIDED AND REVIEWED BY A HEALTH CARE PROFESSIONAL. REVIEW OF THE AVAILABLE RECORDS IDENTIFIED THE FOLLOWING: SEVERE RIGHT KNEE ARTHROPLASTY VARUS MALALIGNMENT WITH METAL-ON-METAL MEDIAL COMPARTMENT CONTACT FROM SEVERE POLYETHYLENE WEAR. DEVICE HISTORY RECORD WAS REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT WERE FOUND. REVIEW OF COMPLAINT HISTORY FOUND NO ADDITIONAL RELATED ISSUES FOR THIS ITEM AND THE REPORTED PART AND LOT COMBINATIONS. ROOT CAUSE WAS UNABLE TO BE DETERMINED. 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.