BIOMET OFFSET TIBIAL TRAY 74MM

Additional Manufacturer Narrative

(B)(4) ADDITIONAL CONCOMITANT MEDICAL PRODUCTS: BIOMET OFFSET TIBIAL TRAY ADAPTOR CATALOG #: 141491 LOT #: 149400, BIOMET SPLINED KNEE STEM WITH SCREW 18MM X 80MM CATALOG #: 141618 LOT #: 169810. THE RETURNED STEM AND OFFSET ADAPTOR WERE EVALUATED AND THE REPORTED MISSASSEMBLY WAS CONFIRMED, HOWEVER, THE SEATING ISSUE WAS NOT VERIFIABLE AS NOT ALL COMPONENTS WERE RETURNED FOR EVALUATION. VISUAL INSPECTION OF THE RETURNED DEVICES NOTED SCRATCHES AND OTHER MARKINGS CONSISTENT WITH BEING EXPLANTED AND THEN REMOVED FROM THE TIBIAL TRAY AS REPORTED. DIMENSIONAL ANALYSIS OF THE GAP BETWEEN THE OFFSET ADAPTOR AND THE STEM DETERMINED THAT THE GAP IS LARGER THAN EXPECTED, INDICATING THAT THE COMPONENTS MAY NOT HAVE BEEN FULLY MATED DURING ASSEMBLY. THE DEVICE HISTORY RECORDS WERE REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT WERE IDENTIFIED. A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED WITH THE INFORMATION PROVIDED. A SUMMARY OF THE INVESTIGATION HAS BEEN SENT TO THE COMPLAINANT. 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 ALL REPORTS ASSOCIATED: 0001825034-2017-07109, 0001825034-2018-09206, 0001825034-2018-09209.

Description of Event or Problem

IT WAS REPORTED THAT THE OFFSET ADAPTER, STEM AND TIBIAL TRAY WERE NOTED TO NOT BE PROPERLY ASSEMBLED DURING KNEE ARTHROPLASTY, RESULTING IN DIFFICULTY SEATING THE DEVICES. THE SURGEON REMOVED THE SCREW AND THE OFFSET ADAPTER WAS THEN DISASSEMBLED FROM THE TIBIAL TRAY, AT WHICH TIME THE OFFSET ADAPTER WAS FOUND TO BE DAMAGED. A REPLACEMENT PART WAS UNAVAILABLE, SO THE SURGEON RE-TRIALED USING A DIFFERENT SIZE. THE CONSTRUCT STILL WOULD NOT FULLY SEAT, SO THE SURGEON REMOVED THE POLYETHYLENE PLUG FROM THE AUGMENT HOLES. THE IMPLANTS WERE THEN ABLE TO BE SEATED SUCCESSFULLY AND THE CASE WAS COMPLETED.