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Description of Event or Problem

ON 24 NOVEMBER 2025 IT WAS REPORTED BY THE ARTHREX CLINICAL RESEARCH TEAM VIA EMAIL THAT WHILE REVIEWING A CLINICAL STUDY, A PATIENT WITH A HISTORY OF LEFT MEDIAL UNICOMPARTMENTAL ARTHROPLASTY PRESENTED SIX YEARS AFTER SURGERY UTILIZING THE IBALANCE UKA AND WAS DOING WELL UP UNTIL APPROXIMATELY TWO MONTHS PRIOR TO THE VISIT, WHICH IS WHEN THE PATIENT STARTED EXPERIENCING LEFT KNEE INSTABILITY. THE PATIENT DENIES ANY TRAUMATIC INJURY. THE CLINICAL EXAM IS CONCERNING FOR CRUCIATE LIGAMENT FAILURE. GIVEN THE FAILURE OF CRUCIATE LIGAMENTS THE HEALTHCARE PROVIDER RECOMMENDED CONVERSION FROM UNI TO TOTAL KNEE ARTHROPLASTY, AND ON (B)(6) 2025 A REVISION WAS PERFORMED FOR A FAILED UKA AND METALLOSIS.

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. 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, POSSIBLY RELATED TO WEAR AND TEAR AFTER SIX YEARS OF IMPLANTATION AND CRUCIATE LIGAMENT FAILURE. THE COMPLAINT ALLEGATION WAS NOT CONFIRMED. NO EVIDENCE OF THAT FAILURE WAS RECEIVED.