UNK

Additional Manufacturer Narrative

ADDITIONAL INFORMATION: D6A, D6B, G3, H3, H6. COMPLAINT ALLEGATION IS NOT CONFIRMED. BASED ON THE INFORMATION PROVIDED WHICH MAY INCLUDE THE DEVICE (IF AVAILABLE AND RETURNED), PICTURES, VIDEOS, EVENT DESCRIPTION, AND ANY ADDITIONAL INFORMATION FROM THE FIELD, ARTHREX WAS ABLE TO CONCLUDE A MOST LIKELY CAUSE. THE DEVICE PERFORMED AS INTENDED, REMAINED PROPERLY POSITIONED AND FIXED, AND DID NOT CONTRIBUTE TO THE REPORTED SYMPTOMS OR NEED FOR REVISION. THE MOST LIKELY CAUSE OF THE REPORTED CLINICAL STUDY IS THE NATURAL PROGRESSION OF DEGENERATIVE JOINT DISEASE IN NON-TREATED KNEE COMPARTMENTS, RATHER THAN A FAILURE OF THE IBALANCE® UKA DEVICE.

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 LEFT KNEE MEDIAL UNICOMPARTMENTAL ARTHROPLASTY UTILIZING IBALANCE UKA ON (B)(6) 2019. DURING FOLLOW-UP ON (B)(6) 2019, PATIENT PRESENTED WITH ONGOING PAIN ON THE MEDIAL AND LATERAL ASPECT OF LEFT KNEE, AS WELL AS SOME SWELLING AND PAIN AT NIGHT. IT WAS NOTED THAT THE INCISION IS HEALING WITHOUT ISSUE. IT WAS NOTED THAT PATIENT IS ONLY ABLE TO AMBULATE WITH A CANE ASSISTIVE DEVICE. RANGE OF MOTION WAS NOTED TO BE ¿EXCELLENT¿ ON PHYSICAL EXAM, AND NO ISSUES WERE NOTED IN RADIOGRAPHS. A MEDROL DOSEPACK WAS PRESCRIBED. DURING FOLLOW-UP ON 10-DEC-2019, PATIENT PRESENTED WITH ONGOING PAIN ON MEDIAL SIDE OF KNEE. PATIENT REPORTED THAT SHE DID HAVE SOME RELIEF WITH THE MEDROL DOSEPACK. PATIENT WAS STILL RELIANT ON CANE FOR AMBULATION. PATIENT WAS PRESCRIBED A LONG STEROID TAPER AND WAS SENT FOR A CT SCAN. DURING FOLLOW-UP ON 21-JAN-2020, PATIENT PRESENTED WITH ONGOING MEDIAL SIDE KNEE PAIN AND ANTERIOR KNEE PAIN. CT SCAN WAS REVIEWED AND SHOWED COMPONENTS WERE WELL-FIXED AND IN ANATOMIC POSITION. ONGOING PAIN WAS ASSESSED AS LIKELY DUE TO PROGRESSION OF ARTHRITIS WITHIN KNEE COMPARTMENTS. PATIENT UNDERWENT REVISION TO TOTAL KNEE ARTHROPLASTY ON (B)(6) 2020.