BIOMET ILOK PRIMARY TIBIAL TRAY

Additional Manufacturer Narrative

(B)(4). CONCOMITANT MEDICAL PRODUCTS: VANGUARD CUSTOM TITANIUM CRUCIATE RETAINING FEMORAL, CAT#: CP113618, LOT#: 170070. BIOMET I-BEAM PRIMARY TIBIAL STEM, CAT#: 141310, LOT#: 974490. VANGUARD TIBIAL BEARING, CAT#: EP-183462, LOT#: 480970. BIOMET SERIES-A STANDARD PATELLA, CAT#: 184764 ,LOT#: 974490. COBALT BONE CEMENT, CAT#: 402283, LOT#: 604040. THE COMPLAINT DEVICE HAS BEEN RETURNED, BUT THE DEVICE INVESTIGATION HAS NOT YET BEEN COMPLETED. ONCE THE EVALUATION IS COMPLETED, A SUPPLEMENTAL MEDWATCH 3500A WILL BE SUBMITTED. 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. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034-2017-07020, 0001825034-2017-07022, 0001825034-2017-07078, 0001825034-2017-07079, 0001825034-2017-07080.

Description of Event or Problem

IT WAS REPORTED THAT THE PATIENT WAS REVISED TO ADDRESS LOOSENING, INFECTION AND WEAR OF COMPONENTS. INTRAOPERATIVELY, METALLOSIS WAS NOTED IN THE JOINT AND SCRATCHES ON THE FEMORAL COMPONENT. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

Additional Manufacturer Narrative

(B)(4). THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. COMPLAINT SAMPLE WAS EVALUATED AND THE REPORTED EVENT WAS CONFIRMED. THE COMPONENT WAS RETURNED AND EVALUATED. VISUAL INSPECTION OF TIBIAL COMPONENT IDENTIFIED SCRATCHES ON THE DEVICE AND THE PRESENCE OF FOREIGN MATERIAL, LIKELY BONE CEMENT, ON THE INFERIOR SIDE OF THE DEVICE. DHR WAS REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT WERE FOUND. 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.