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, IT WAS NOTED THAT A PATIENT WHO HAD A RIGHT KNEE MEDIAL UNICOMPARTMENTAL ARTHROPLASTY ON (B)(6) 2018 UTILIZING IBALANCE UKA, PRESENTED WITH WORSENING RIGHT KNEE PAIN DURING FOLLOW-UPS ON (B)(6) 2020. X-RAYS TAKEN ON (B)(6) 2020 SHOWED LOOSENING OF THE TIBIAL COMPONENT. INFECTIOUS WORK-UP WAS NEGATIVE. PATIENT UNDERWENT REVISION TO A TOTAL KNEE ARTHROPLASTY ON (B)(6) 2020.

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 BIOLOGICAL RESPONSE. THE COMPLAINT ALLEGATION WAS NOT CONFIRMED. NO EVIDENCE OF THAT FAILURE WAS RECEIVED.