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Description of Event or Problem

ON (B)(6) 2025 IT WAS REPORTED BY THE ARTHREX CLINICAL RESEARCH TEAM VIA EMAIL THAT WHILE REVIEWING A CLINICAL STUDY, A PATIENT STATUS POST LEFT KNEE MEDIAL UNICOMPARTMENTAL ARTHROPLASTY UTILIZING THE IBALANCE UKA IN (B)(6) 2018 INITIALLY DID VERY WELL BUT NOW HAS HAD PROGRESSIVE LEFT KNEE PAIN, A VARUS DEFORMITY, AND SOME STIFFNESS. THE HEALTHCARE PROVIDER REPORTS THAT X-RAYS CONFIRM FAILURE OF HIS UNICOMPARTMENTAL ARTHROPLASTY, AND THERE IS DEMONSTRATION OF ACL INSUFFICIENCY WITH POSTERIOR TRANSLATION OF THE FEMUR IN REGARD TO THE TIBIA. THERE IS SOME SUBSIDENCE OF THE TIBIA COMPONENT, THE PATIENT IS FALLING INTO FURTHER VARUS, AND THERE IS NOW BONE-ON-BONE TO THE LATERAL COMPARTMENT. CT CONFIRMS THE FINDINGS AND LABS ARE WITHIN NORMAL LIMITS. ON (B)(6) 2024 A REVISION WAS PERFORMED DUE TO PAIN AND SWELLING.

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