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 11/24/2025 IT WAS REPORTED BY THE ARTHREX CLINICAL RESEARCH TEAM VIA EMAIL THAT THE FOLLOWING INFORMATION WAS OBTAINED BY A CLINICAL STUDY: (B)(4) SEVERAL YEARS POST MEDIAL ARTHROPLASTY THE PATIENT EXPERIENCED A FALL AND REPORTED PAIN. ON (B)(6) 2022, PATIENT REPORTED BILATERAL KNEE PAIN. SHE HAD A RIGHT UNICOMPARTMENTAL KNEW PERFORMED IN 2018 AND WAS DOING WELL UNTIL A RECENT FALL IN 2021. ON (B)(6) 2023, THE PATIENT IS SCHEDULED FOR A RIGHT UNICOMPARTMENTAL KNEE ARTHROPLASTY CONVERSION TO A TOTAL KNEE ARTHROPLASTY ON (B)(6) 2023. THE DEVICES WERE EXPLANTED ON (B)(6) 2023.

Additional Manufacturer Narrative

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 FACTOR, SUCH AS A FALL. THE COMPLAINT ALLEGATION WAS NOT CONFIRMED. NO EVIDENCE OF THAT FAILURE WAS RECEIVED.