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 EVENT AND PRE-EXISTING HEALTH CONDITIONS. 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 BY THE ARTHREX CLINICAL RESEARCH TEAM VIA EMAIL THAT WHILE REVIEWING A CLINICAL STUDY, IT WAS NOTED ON (B)(6) 2021, 1.4 YEARS STATUS POST RIGHT MEDIAL UNICOMPARTMENTAL ARTHROPLASTY THE PATIENT HAD DEVELOPED A FAIR AMOUNT OF PAIN WITH INCREASED ACTIVITY. IT WAS REPORTED CLINICALLY, THE PATIENT LOOKED VERY GOOD RADIOGRAPHICALLY, BUT THE TIBIAL SIDE WAS CONCERNING FOR TIBIAL LOOSENING. ON (B)(6) 2021, THE PATIENT WAS HAVING INCREASING PAIN WITH ACTIVITY, MOSTLY OVER THE TIBIA. A CT SCAN SHOWED LUCENCY AROUND THE TIBIAL COMPONENT. SUBLUXATION, LOADING, AND LOOSENING OF THE TIBIAL COMPONENT WERE DISCUSSED WITH THE PATIENT WHO WISHED TO PROCEED WITH REVISION OF IBALANCE UKA TOTAL KNEE ARTHROPLASTY. THE DEVICES WERE EXPLANTED ON (B)(6) 2021.

Additional Manufacturer Narrative

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