PATELLO-FEMORAL TROCHLEA COMPONENT PRECOAT

Additional Manufacturer Narrative

(B)(4). CONCOMITANT MEDICAL PRODUCTS: CATALOG #: 00584201302, FEMORAL COMPONENT HIGH FLEX PRECOAT, LOT # 62827179. CATALOG #: 00584202408, ARTICULAR SURFACE SIZE 4, LOT # 62697221. CATALOG #: 00584200402, TIBIAL COMPONENT PRECOAT, LOT # 62828687. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, DUE TO BEING DISCARDED. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. 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. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT; PLEASE SEE ASSOCIATED REPORTS: 0001822565-2018-07028.

Description of Event or Problem

IT WAS REPORTED THAT A PATIENT UNDERWENT AN INITIAL KNEE PROCEDURE ON APPROXIMATELY 3 YEARS AGO. SUBSEQUENTLY, THE PATIENT WAS REVISED DUE TO PAIN, LOOSENING, AND INSTABILITY.

Additional Manufacturer Narrative

(B)(4). REPORTED EVENT WAS CONSIDERED TO BE CONFIRMED AS THE REPORTED HARMS WERE NOTED IN THE MEDICAL RECORDS. THE X-RAY ALSO NOTED LOOSENING AND POSSIBLE JOINT EFFUSION. DEVICE HISTORY RECORD 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. THERE ARE WARNINGS IN THE PACKAGE INSERT THAT THIS TYPE OF EVENT CAN OCCUR AND RISKS ARE ADDRESSED IN RISK DOCUMENTATION. A SUMMARY OF THE INVESTIGATION WAS SENT TO THE COMPLAINANT CONVEYING PROPER SURGICAL TECHNIQUE AND USE OF THE DEVICE. 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.