SERIES A PAT STD 31 3 PEG

Additional Manufacturer Narrative

(B)(4). MEDICAL PRODUCT: VGXP XP INLK PRI TIB TRAY CATALOG # 195752, LOT # 716040; VGXP INTLK FEMORAL RT CATALOG # 195910, LOT # 872820; VGXP XP E1 TIB BRG RL CATALOG # 195773, LOT # 499430; VGXP XP E1 TIB BRG RM CATALOG # 195843, LOT # 433370; R & B BONE CEMENT CATALOG # UNKNOWN LOT # 82054447. THE COMPLAINANT 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: 0001825034-2020-01494, 0001825034-2020-01495, 0001825034-2020-01497, 0001825034-2020-01499.

Description of Event or Problem

IT WAS REPORTED THAT THE PATIENT UNDERWENT RIGHT TOTAL KNEE ARTHROPLASTY. SUBSEQUENTLY, THE PATIENT HAS EXPERIENCED PAIN, SWELLING AND INSTABILITY SINCE HER PROCEDURE. PATIENT FALLS OFTEN ALLEGEDLY CAUSED BY THE KNEE IMPLANTS. NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

Description of Event or Problem

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

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. THE CONTACT WAS SENT THE INVESTIGATION RESULTS. 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.