E-POLY 36MM +3 HIWALL LNR SZ23

Additional Manufacturer Narrative

(B)(4). CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, AS THE DEVICE REMAINS IMPLANTED. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. EVENT DATE-ONSET OF PAIN OCCURRED ON AN UNKNOWN DAY IN 2001 CONCOMITANT MEDICAL PRODUCTS: ITEM # UNK, HIP-UNKNOWN-STEMS-UNK, LOT # UNK, ITEM # 650-1057, FEMORAL HEAD, LOT # 316860, ITEM # 650-1062, TAPER ADAPTER, LOT # 525920, ITEM # 11-105150, CUP, LOT # 138250. MULTIPLE REPORTS HAVE BEEN SUBMITTED FOR THIS EVENT. PLEASE SEE ASSOCIATED REPORTS: 0001825034-2018-04177, 0001825034-2018-04178, 0001825034-2018-04179, 0001825034-2014-00478, 0001825034-2018-04180.

Description of Event or Problem

IT WAS REPORTED THAT A PATIENT IS CURRENTLY EXPERIENCING ONGOING PAIN APPROXIMATELY 6 YEARS POST IMPLANTATION. ATTEMPTS HAVE BEEN MADE, AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

Additional Manufacturer Narrative

REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. DEVICE HISTORY RECORD (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. 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.