UNKNOWN E-POLY HI WALL RINGLOC ACETABULAR LINER

Additional Manufacturer Narrative

CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A CONCLUSION AS TO THE CAUSE OF THE EVENT. THIS REPORT IS BASED ON ALLEGATIONS SET FORTH IN PLAINTIFF¿S COMPLAINT, AND THE ALLEGATIONS CONTAINED THEREIN ARE UNVERIFIED.

Description of Event or Problem

LEGAL COUNSEL FOR PATIENT REPORTED PATIENT¿S RIGHT HIP WAS REVISED APPROXIMATELY SIX YEARS POST IMPLANTATION DUE TO UNKNOWN REASONS. DURING THE PROCEDURE, THE ACETABULAR CUP AND LINER WERE REMOVED AND REPLACED. THIS REPORT IS BASED ON ALLEGATIONS SET FORTH IN PLAINTIFF¿S COMPLAINT AND THE ALLEGATIONS CONTAINED THEREIN ARE UNVERIFIED.

Additional Manufacturer Narrative

(B)(4). CONCOMITANT PRODUCTS: SELEX/MAGNUM FEMORAL HEAD CATALOG#: S031140 LOT#: 744980, ECHO BI-METRIC FEMORAL STEM CATALOG#: 192012 LOT#: 190370, MALLORY HEAD ACETABULAR CUP CATALOG#: 13-104154 LOT#:101710, LOW PROFILE SCREW CATALOG#: 103532 LOT#'S: 618940 & 618810. 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.

Additional Manufacturer Narrative

THIS FOLLOW-UP REPORT IS BEING FILED TO RELAY ADDITIONAL INFORMATION, WHICH WAS UNKNOWN AT THE TIME OF THE INITIAL MEDWATCH.