PERSONA VIVACITE ARTICULAR SURFACE

Additional Manufacturer Narrative

THIS REPORT WILL BE AMENDED WHEN OUR INVESTIGATION IS COMPLETE.

Description of Event or Problem

IT IS REPORTED THAT THE PATIENT WAS REVISED DUE TO INSTABILITY IN THE RIGHT KNEE.

Additional Manufacturer Narrative

REPORTED EVENT COULD NOT BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. DHR WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. REVIEW OF COMPLAINT HISTORY DETERMINED THAT NO FURTHER ACTION IS REQUIRED AS NO TRENDS WERE IDENTIFIED. THE ASSOCIATED PACKAGE INSERT WARNS THAT THIS TYPE OF EVENT CAN OCCUR. UNDER ¿ADVERSE EFFECTS¿ IT LISTS ¿DISLOCATION AND/OR JOINT INSTABILITY¿ AS AN ADVERSE EFFECT OF THIS PROCEDURE. ROOT CAUSE COULD NOT 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.

Additional Manufacturer Narrative

THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL AND CORRECTED INFORMATION. REPORTED EVENT WAS CONFIRMED THROUGH A REVIEW OF PATIENT'S MEDICAL RECORDS, WHICH INDICATED THE PATIENT WAS REVISED DUE TO INSTABILITY. DHR WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. REVIEW OF COMPLAINT HISTORY DETERMINED THAT NO FURTHER ACTION IS REQUIRED AS NO TRENDS WERE IDENTIFIED. THE ASSOCIATED PACKAGE INSERT WARNS THAT THIS TYPE OF EVENT CAN OCCUR. UNDER ¿ADVERSE EFFECTS¿ IT LISTS ¿DISLOCATION AND/OR JOINT INSTABILITY¿ AS AN ADVERSE EFFECT OF THIS PROCEDURE. ROOT CAUSE COULD NOT 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.