UNK

Additional Manufacturer Narrative

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

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, A PATIENT HAD AN EIGHT WEEK FOLLOW UP ON (B)(6) 2018 FOR A LEFT KNEE MEDIAL UNICOMPARTMENTAL ARTHROPLASTY UTILIZING THE IBALANCE UKA. THERE HAVE BEEN ISSUES WITH PAIN OVER THE PAST FEW WEEKS. ORAL STEROIDS IMPROVED SWELLING, BUT IT'S UNKNOWN IF THEY HELPED WITH PAIN. A PREVIOUS INFECTIOUS WORKUP WAS NEGATIVE FOR INFECTION. THE PAIN IS NOTED UPON AMBULATING AND AFTER PHYSICAL THERAPY. ON (B)(6) 2018 THE PATIENT IS REPORTING IMPROVEMENT AND HAS GRADUATED PHYSICAL THERAPY. THE HEALTHCARE PROVIDER REPORTS RESIDUAL PAIN IS LIKELY DUE TO SOME QUAD ATROPHY AND BIOMECHANICAL ADJUSTMENT IN HER GAIT. ON (B)(6) 2020 THE PATIENT HAD AN EVALUATION OF LEFT KNEE PAIN AND SWELLING. THE PATIENT HAS AN ELEVATED CRP, AND ASPIRATION SHOWED AN ELEVATED WHITE COUNT BUT NOT A SIGNIFICANTLY HIGH NEUTROPHIL PERCENTAGE. ON (B)(6) 2023 THE PATIENT HAD A REVISION FOR FAILURE OF UKA DUE TO INSTABILITY AND ADJACENT COMPARTMENT OSTEOARTHRITIS.

Additional Manufacturer Narrative

ADDITIONAL INFORMATION: G3, H3, H6. THE COMPLAINT DEVICE WAS NOT RECEIVED FOR EVALUATION. BASED ON THE INFORMATION PROVIDED, WHICH MAY INCLUDE THE RETURNED DEVICE (IF AVAILABLE), PICTURES, VIDEOS, EVENT DESCRIPTIONS, AND ANY ADDITIONAL FIELD DATA, ARTHREX CONCLUDED THE MOST LIKELY CAUSE OF THE REPORTED FAILURE. THE MOST LIKELY CAUSE OF THE REPORTED FAILURE IS A PATIENT-SPECIFIC EVENT AND PRE-EXISTING HEALTH CONDITIONS. THE COMPLAINT ALLEGATION WAS NOT CONFIRMED. NO EVIDENCE OF THAT FAILURE WAS RECEIVED.