UNK

Additional Manufacturer Narrative

ADDITIONAL INFORMATION: D6A, D6B, 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 AND PRE-EXISTING HEALTH CONDITIONS, INCLUDING ABNORMAL WEAR, INSTABILITY, AND KNEE ARTHROFIBROSIS. THE COMPLAINT ALLEGATION WAS NOT CONFIRMED. NO EVIDENCE OF THAT FAILURE WAS RECEIVED.

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) 2020. ON (B)(6) 2020, PATIENT PRESENTED WITH CONTINUOUS PAIN OVER SURGICAL SITE AT THE MEDIAL JOINT LINE. PAIN IS PRESENT AT REST AND IS WORSE WHEN WEIGHTBEARING. PATIENT STATES HER KNEE FEELS LIKE IT WAS ¿GIVING OUT TWICE BUT OTHERWISE FEELS STABLE.¿ PATIENT WAS NOTED TO HAVE GOOD RANGE OF MOTION, AND NO REDNESS, STIFFNESS, OR SIGNIFICANT SWELLING WAS NOTED. PATIENT STATES IT IS BEGINNING TO LIMIT HER ABILITY TO PERFORM DAILY ACTIVITIES. PATIENT STATES SHE HAS BEEN RELIANT ON TYLENOL ARTHRITIS THAT PROVIDES MODEST RELIEF AND COUPLING IT WITH ALEVE. RADIOGRAPHS WERE OBTAINED DURING THE VISIT. IT WAS NOTED THAT THERE WAS CONCERN FOR TIBIAL BASEPLATE LOOSENING, AND MALROTATION OF THE FEMORAL COMPONENT, WHICH APPEARED TO BE SLIGHTLY PROGRESSIVE SINCE HER LAST X-RAYS AT THE 6-MONTH MARK. DUE TO FAILED UKA WITH ABNORMAL WEAR AND INSTABILITY AND KNEE ARTHROFIBROSIS, THE PATIENT UNDERWENT REVISION ON (B)(6) 2021.

Additional Manufacturer Narrative

INVESTIGATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE PROVIDED UPON AVAILABILITY OF ADDITIONAL INFORMATION.