E1 RINGLOC ACETABULAR LINER 36 MM SIZE 23 +3 HI-WALL

Additional Manufacturer Narrative

(B)(4). MEDICAL PRODUCTS - BIO-MOORE FEMORAL STEM CATALOG#: 139205 LOT#: 718610, RINGLOC ACETABULAR CUP CATALOG#: PT-116052 LOT#: 962630, LOW PROFILE SCREW CATALOG#: 103534 LOT#: 815370, FEMORAL HEAD CATALOG#: 11-363663 LOT#: 725430. UPON THIRD-PARTY REVIEW OF X-RAYS RECEIVED, LOOSENING AND MIGRATION OF THE ACETABULAR CUP, ACETABULAR RADIOLUCENCIES AND A FRACTURED ACETABULAR SCREW WERE NOTED. REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. DHR WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. ROOT CAUSE WAS UNABLE TO BE DETERMINED, AS THE NECESSARY INFORMATION TO ADEQUATELY INVESTIGATE THE REPORTED EVENT WAS NOT PROVIDED. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTRIBUTE TO MONITOR FOR TRENDS. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT. PLEASE SEE ASSOCIATED REPORTS: 0001825034-2016-04251, 0001825034-2017-04095, 0001825034-2017-04096.

Description of Event or Problem

IT WAS REPORTED THAT PATIENT UNDERWENT A RIGHT HIP REVISION PROCEDURE APPROXIMATELY SEVEN YEARS POST-IMPLANTATION DUE TO HIP DISLOCATION. DURING THE PROCEDURE, THE FEMORAL HEAD, ACETABULAR CUP AND ACETABULAR LINER WERE REMOVED AND REPLACED.