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Description of Event or Problem

ON 11/10/2025 IT WAS REPORTED VIA EMAIL BY ARTHREX REGULATORY THAT AFTER REVIEWING A CLINICAL STUDY THEY DISCOVERED THAT A PATIENT HAD DEVELOPED COMPLICATIONS FOLLOWING A HIGH TIBIAL OSTEOTOMY (HTO) PROCEDURE USING THE IBALANCE HTO SYSTEM IN 2018. IT WAS NOTED THAT A FAILURE OF THE OSTEOTOMY OCCURRED WITHIN 5 MONTHS OF SURGERY. THE PATIENT WAS WEIGHT BEARING WITHOUT THE AID OF CRUTCHES AT DAY 35 POST-OPERATIVE. DESPITE AN ACCEPTABLE LOSS OF CORRECTION AT 6 WEEKS POSTOPERATIVE (1.4°), THE PATIENT WENT ON TO OPEN UP THROUGH THE LATERAL CORTEX HINGE, MEDIALLY, PRESENTING AT THE 3 MONTH VISIT WITH INCREASING VARUS DEFORMITY AND PAIN. THE PATIENT WAS REPORTED AS NON-COMPLIANT WITH CESSATION OF TOBACCO USE AND WENT ON TO AN UNEVENTFUL CONVERSION TO A TOTAL KNEE ARTHROPLASTY.

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. 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 MOST LIKELY CAUSE OF THE REPORTED FAILURE CAN BE ATTRIBUTED TO A PATIENT-SPECIFIC EVENT RATHER THAN DEVICE PERFORMANCE OR MALFUNCTION OF THE IBALANCE HTO SYSTEM DUE TO A COMBINATION OF PREMATURE WEIGHT-BEARING AND THE PATIENT¿S NON-COMPLIANCE WITH TOBACCO CESSATION, BOTH OF WHICH NEGATIVELY AFFECT BONE HEALING AND STABILITY.