UNK

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 BY THE ARTHREX CLINICAL RESEARCH TEAM VIA EMAIL THAT WHILE REVIEWING A CLINICAL STUDY, IT WAS NOTED ON (B)(6) 2020 A PATIENT HAD AN EVALUATION EIGHT WEEK STATUS POST LEFT MEDIAL IBALANCE UKA AND COMPLAINED OF PAIN. THERE WAS A SETBACK WITH THERAPY AND THE PATIENT WASN'T ABLE TO ATTEND. CLINICALLY THE PATIENT LOOKED WELL, FLEXED 20°, AND WAS ALMOST AT FULL EXTENSION. THERE WAS A FAIR AMOUNT OF SWELLING AND WARMTH AS WOULD BE EXPECTED. THE PATIENT RESUMED THERAPY. AN EVALUATION ON (B)(6) 2020 SHOWED THAT INFLAMMATION IS BETTER AND MOTION WAS VERY GOOD. CLINICALLY THINGS APPEAR IMPROVED, BUT THE PATIENT WAS STILL HAVING PAIN. SIX MONTHS AFTER SURGERY, THE PATIENT REPORTED CONTINUED PAIN AND STIFFNESS. THE PATIENT ALSO COMPLAINED OF HYPEREXTENSION INSTABILITY AND OF INTERMITTENT MECHANICAL SYMPTOMS INCLUDING POPPING AND CATCHING. THE PATIENT EXPRESSED DISSATISFACTION WITH THEIR KNEE DESPITE EVALUATIONS INCLUDING A COMPLETE REVIEW OF A CAT SCAN SHOWING NO SPECIFIC ABNORMALITIES. A REVISION WAS PERFORMED ON (B)(6) 2021 FOR FAILURE OF UKA IMPLANT.

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