UNK

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.

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 VIA EMAIL BY THE ARTHREX CLINICAL RESEARCH TEAM THAT THE FOLLOWING INFORMATION WAS OBTAINED FROM A CLINICAL STUDY: PATIENT UNDERWENT RIGHT KNEE MEDIAL UNICOMPARTMENTAL ARTHROPLASTY UTILIZING IBALANCE UKA ON (B)(6) 2020. DURING FOLLOW-UP ON (B)(6) 2021, IT WAS NOTED THAT PATIENT HAS ONGOING KNEE PAIN SINCE INITIAL SURGERY. PATIENT STATED HE HAS NOT HAD SUBSTANTIAL RELIEF FROM THE SURGERY. THE PATIENT INDICATED THE PAIN IS LOCALIZED TO THE MEDIAL JOINT LINE AND MEDIAL PATELLA. PREVIOUS TREATMENTS HAVE INCLUDED PRIOR KNEE SURGERY, WHICH HAS PROVIDED NO RELIEF. THE PATIENT HAS DIFFICULTY WITH FOLLOWING ACTIVITIES: WALKING FOR LONG DISTANCES, CLIMBING STAIRS, STANDING FOR LONG PERIODS OF TIME AND ANY TWISTING AND TURNING MOTION, DUE TO RIGHT KNEE PAIN. THE PATIENT DENIES ANY TRAUMA TO THE RIGHT LOWER EXTREMITY. THE PATIENT HAS NO PREVIOUS SURGICAL HISTORY WITH REGARDS TO RIGHT KNEE. THE PATIENT DENIES ANY NUMBNESS, OR STIFFNESS IN THE INVOLVED EXTREMITY. DUE TO FAILURE OF THE UKA, PATIENT UNDERWENT REVISION SURGERY ON (B)(6) 2022.