RINGLOC BI-POLAR 28X42MM

Additional Manufacturer Narrative

(B)(4). D10: FEMORAL HEAD 12/14 TAPER 28 MM DIAMETER -3.5 NECK LENGTH, ITEM: 802202801, LOT: UNKNOWN. G2: FOREIGN ¿ ISRAEL. THE LOCATION OF THE REPORTED DEVICE IS UNKNOWN AT THIS TIME; THEREFORE, IT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A SUPPLEMENTAL MDR WILL BE SUBMITTED.

Description of Event or Problem

IT WAS REPORTED THAT THE PATIENT UNDERWENT A PARTIAL HIP REPLACEMENT USING A RINGLOC SYSTEM. SUBSEQUENTLY, THE PATIENT WAS REVISED APPROXIMATELY 13 DAYS POST-IMPLANTATION DUE TO DISLOCATION. IT WAS NOTED THAT THE METALLIC FEMORAL HEAD DISSOCIATED FROM THE SYSTEM'S POLYETHYLENE LINER. FOLLOW-UPS TO GATHER ADDITIONAL INFORMATION ARE CURRENTLY IN PROCESS.