BIOMET CC CRUCIATE TRAY 75MM

Description of Event or Problem

NO ADDITIONAL INFORMATION REPORTED.

Additional Manufacturer Narrative

THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. REVIEW OF PROVIDED PICTURES CONFIRMS THE LOCKING BAR HAS BACKED OUT OF ITS INTENDED LOCKED POSITION; IT IS STILL PARTIALLY IN THE BASEPLATE/POLYETHYLENE INTERFERENCE AND NO DAMAGE IS CLEARLY VISIBLE ON THE LOCKING BAR. FURTHER ANALYSIS, INCLUDING DIMENSIONAL ANALYSIS COULD NOT BE COMPLETED BECAUSE THE PRODUCT WAS NOT RETURNED. DEVICE HISTORY RECORD WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

Additional Manufacturer Narrative

(B)(4). CONCOMITANT MEDICAL PRODUCTS: INTRAMEDULLARY PLUG LGE CATALOG 130613 LOT 949880, VANGUARD CR ILOK FEM-RT 72.5 CATALOG 183013 LOT J6357372, SERIES A PAT THN 34 3 PEG CATALOG 184786 LOT 155370, E1 VNGD AS TIB BRG 16X75 CATALOG EP-189086 LOT 537470. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION AS IT WAS DISCARDED BY THE USER FACILITY. 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 DURING A FOLLOW UP APPROXIMATELY THREE WEEKS POST KNEE ARTHROPLASTY, THE LOCKING BAR WAS NOTED TO HAVE BACKED OUT OF THE TIBIAL TRAY. THE PATIENT THEN UNDERWENT A REVISION TO REPLACE THE LOCKING BAR AND TIBIAL BEARING. NO ADDITIONAL INFORMATION IS AVAILABLE.