BIOMET E-POLY LINER

Additional Manufacturer Narrative

(B)(4). CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, AS IT WAS REQUESTED, BUT NOT RETURNED BY THE HOSPITAL. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. CONCOMITANT MEDICAL PRODUCTS: ITEM # 11-363660, FEMORAL HEAD, LOT # 641190, ITEM # 12-104158, SHELL, LOT # 972760, ITEM # HIPS-UNKNOWN-STEMS-UNK, LOT # UNK. (B)(6).

Description of Event or Problem

IT WAS REPORTED THAT THE PATIENT UNDERWENT A REVISION SURGERY APPROXIMATELY 6 YEARS POST IMPLANTATION DUE TO POLY LINER WEAR. ATTEMPTS HAVE BEEN MADE, AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

Additional Manufacturer Narrative

THIS FOLLOW UP REPORT IS BEING SUBMITTED TO REPORT ADDITIONAL INFORMATION. REPORTED EVENT WAS CONFIRMED THROUGH PHOTOGRAPHS RECEIVED. PHOTOGRAPHS OF THE EXPLANTED HEAD AND LINER WERE PROVIDED. THE LINER IS COMPLETELY WORN AND FRACTURED INTO MULTIPLE PIECES AND SCRATCHES WERE NOTED ON EXPLANTED COCR HEAD OUTER SURFACE. HOWEVER, NO FURTHER EVALUATION CAN BE PERFORMED BASED USING THE PHOTOGRAPHS PROVIDED AND DIMENSIONAL EVALUATIONS COULD NOT BE PERFORMED SINCE THE PRODUCT IS NOT RETURNED. DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. REVIEW OF COMPLAINT HISTORY DETERMINED THAT NO FURTHER ACTION IS REQUIRED. ROOT CAUSE WAS UNABLE TO BE DETERMINED. 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.