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 VIA EMAIL BY THE ARTHREX CLINICAL RESEARCH TEAM THAT THE FOLLOWING INFORMATION WAS OBTAINED FROM A CLINICAL STUDY: PATIENT UNDERWENT RIGHT KNEE MEDIAL UNICOMPARTMENTAL ARTHROPLASTY UTILIZING IBALANCE UKA ON (B)(6) 2020. IT WAS NOTED THAT PATIENT HAD ¿DONE VERY WELL¿ SINCE HIS SURGERY. DURING FOLLOW-UP VISIT ON (B)(6) 2022, PATIENT STATED THAT HE STARTED NOTICING MORE PAIN AFTER GOING ON VACATION IN (B)(6) 2021. HE HAS TEMPORARY PAIN, RATED AS UP TO 5/10, UPON STANDING. PAIN FEELS BETTER WHEN WALKING. PATIENT DENIED CATCHING OR LOCKING SYMPTOMS. PAIN IS RELIEVED BY IBUPROFEN. PATIENT STATED THAT HIS KNEE ¿HAS NEVER BEEN ABLE TO BE COMPLETELY STRAIGHT¿ AND NOTICES IT COMPARED TO THE OTHER KNEE WHEN STANDING. DUE TO FAILED UKA, PATIENT UNDERWENT REVISION SURGERY ON (B)(6) 2023.

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.