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Description of Event or Problem

ON 24-NOV-2025, IT WAS REPORTED BY THE ARTHREX CLINICAL RESEARCH TEAM VIA EMAIL THAT WHILE REVIEWING A CLINICAL STUDY, IT WAS NOTED THAT A PATIENT POST THE IBALANCE UKA ON THE LEFT, ON (B)(6) 2018. THEY WALKED INTO THE OFFICE WITH KNEE SWELLING, ON (B)(6) 2019, AFTER BEING SENT BY PT. STAT LABS ORDERED AND CRP AND ESR ARE ELEVATED. THE PATIENT REPORTS HAVING SWELLING SINCE SURGERY, AND IT'S GOTTEN SLIGHTLY WORSE OVER THE PAST MONTH. WARMTH WAS REPORTED, BUT FEVER AND CHILLS WERE DENIED. IT WAS REPORTED THAT SOMETIMES KNEE LOCKS WHEN STANDING FROM A STANDING POSITION. THE HEALTHCARE PROVIDER REPORTED CRP & SED SHOULD NOT BE ELEVATED AT THIS POINT AND AN ASPIRATION WAS NEEDED. THE PATIENT WAS ADVISED THAT THE CELL COUNT INDICATES INFECTION, AND IT WAS RECOMMENDED TO DO AN I&D AND POLY EXCHANGE FOLLOWED BY 6 WEEKS OF IV ANTIBIOTICS. ON (B)(6) 2019, THE PATIENT UNDERWENT A REVISION FOR LOOSENING OF TIBIAL COMPONENT OF UKA AND PRESUMED PROSTHETIC JOINT INFECTION.

Additional Manufacturer Narrative

INVESTIGATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE PROVIDED UPON AVAILABILITY OF ADDITIONAL INFORMATION.

Additional Manufacturer Narrative

ADDITIONAL INFORMATION: G3, H3, H6. BASED ON THE INFORMATION PROVIDED WHICH MAY INCLUDE THE DEVICE (IF AVAILABLE AND RETURNED), PICTURES, VIDEOS, EVENT DESCRIPTION, AND ANY ADDITIONAL INFORMATION FROM THE FIELD, ARTHREX WAS ABLE TO CONCLUDE A MOST LIKELY CAUSE. THE MOST LIKELY CAUSE FOR THE REPORTED FAILURE CAN BE ATTRIBUTED TO A PATIENT-SPECIFIC EVENT DUE TO THE OCCURRENCE OF THE INFECTION IN THE PATIENT'S KNEE.