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Description of Event or Problem

ON 24-NOV-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) 2018. DURING FOLLOW-UP ON (B)(6) 2018, PATIENT REPORTED AN INCREASE IN PAIN AND SWELLING ¿RECENTLY¿, BUT SINCE THE ONSET, THE SYMPTOMS HAD IMPROVED. PATIENT HAD LABS DRAWN AND HAD ULTRASOUND, WITH RESULTS WITHIN NORMAL LIMITS. RADIOGRAPHS WERE TAKEN, WITH NO NOTED ISSUES. MEDROL DOSEPACK WAS PRESCRIBED. DURING FOLLOW-UP ON (B)(6) 2018, PATIENT PRESENTED WITH INCREASED PAIN AND SWELLING THAT STARTED 2 WEEKS PRIOR, WITH NO SPECIFIC INJURY. IT WAS NOTED THAT THE INCISION WAS WELL-HEALED. ON (B)(6) 2018, PATIENT PRESENTED TO ER WITH MUCH WORSE PAIN AND FEVER OF 101.4. THE PATIENT WAS DIAGNOSED WITH ACUTE HEMATOGENOUS INFECTION OF UKA IMPLANT. PATIENT UNDERWENT EXTENSIVE SYNOVECTOMY AND IRRIGATION AND DEBRIDEMENT WITH POLYETHYLENE EXCHANGE ON (B)(6) 2018.

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