BIOMET OFFSET TIBIAL TRAY ADAPTER

Additional Manufacturer Narrative

(B)(4). UDI: (B)(4). CONCOMITANT MEDICAL PRODUCT: BIOMET SPLINED KNEE STEM, CAT#: 141618 LOT#: 169810. BIOMET OFFSET TIBIAL TRAY, CAT#: 141484 LOT#: 212390. CUSTOMER HAS INDICATED THAT THE PRODUCT IS IN PROCESS OF BEING RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR 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.

Description of Event or Problem

IT WAS REPORTED THAT THE OFFSET ADAPTER WAS NOT FULLY SEATED. IT WAS NOTED THAT THE IMPLANTS WERE NOT ASSEMBLED CORRECTLY. THE SCREW WAS REMOVED 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 WOULD NOT FULLY SEAT SO THE SURGEON REMOVED THE POLYETHYLENE PLUG FROM THE AUGMENT HOLES. THE IMPLANTS THEN SEATED AND THE CASE WAS COMPLETED.

Additional Manufacturer Narrative

THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL AND CORRECTED INFORMATION. IMPLANT DATE - THIS DEVICE WAS NOT IMPLANTED. THE RETURNED STEM AND OFFSET ADAPTOR WERE EVALUATED AND THE REPORTED MISASSEMBLY 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.