BIOMET CC CRUCIATE TRAY 75MM

Additional Manufacturer Narrative

THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. DEVICE WAS NOT RETURNED. DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT 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 CONTINUE TO MONITOR FOR TRENDS.

Description of Event or Problem

NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

Additional Manufacturer Narrative

(B)(4). MEDICAL PRODUCT: VAN PS OPEN INTL FEM-LT 70 CATALOG # 183132 LOT # 490110, VNGD PS TIB BRG 14X71/75MM CATALOG # 183644 LOT # 231070, SERIES A PAT STD 31 3 PEG CATALOG # 184764 LOT # 380260, STBLECUT HYPERBLADE AO/SD .054 CATALOG # 907238 LOT # 506104, COBALT G-HV BONE CEMENT 40G CATALOG # 402283 LOT # 849960, COBALT G-HV BONE CEMENT 40G CATALOG # 402283 LOT # 590590, OPTIVAC KIT 80GRAM DOUBLE MIX CATALOG # 417200 LOT # 1904362, 1/8 QUICK REL DRL STERILE 2PK CATALOG # 32-486265 LOT # 368110. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED BECAUSE IT REMAINS IMPLANTED. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. MULTIPLE MDR REPORTS WERE FILLED FOR THIS EVENT: 0001825034-2020-00334, 0001825034-2020-00335, 0001825034-2020-00337. REMAINS IMPLANTED.

Description of Event or Problem

IT WAS REPORTED THAT THE PATIENT UNDERWENT A KNEE ARTHROPLASTY. SUBSEQUENTLY, THE PATIENT WILL BE CONSIDERED FOR REVISION DUE TO PAIN. NO REVISION PROCEDURE HAS BEEN REPORTED TO DATE. ATTEMPT FOR FURTHER INFORMATION HAS BEEN MADE, BUT NO FURTHER INFORMATION HAS BEEN PROVIDED.