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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 ON (B)(6) 2020 A PATIENT TWO YEARS AFTER SURGERY FOR A LEFT KNEE MEDIAL UNICOMPARTMENTAL KNEE ARTHROPLASTY UTILIZING IBALANCE UKA WOKE UP WITH A PAINFUL AND LOCKED KNEE EARLIER IN THE WEEK. PREDNISONE WAS ORDERED AND HAS HELPED BRING DOWN SOME OF THE PAIN BUT THE MECHANICAL SYMPTOMS OF THE KNEE REMAIN. THE PATIENT IS VERY TENDER TO THE MEDIAL ASPECT. ON (B)(6) 2020 A REVISION WAS PERFORMED FOR FAILED UKA, ADVANCEMENT OF ARTHRITIC CHANGES, AND LATERAL PATELLOFEMORAL JOINT.

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, A POSSIBLE WEAR AND TEAR OF THE IMPLANT AFTER TWO YEARS OF IMPLANTATION. THE COMPLAINT ALLEGATION WAS NOT CONFIRMED. NO EVIDENCE OF THAT FAILURE WAS RECEIVED.