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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 EVENT AND PRE-EXISTING HEALTH CONDITIONS, INCLUDING ABNORMAL WEAR, INSTABILITY, AND KNEE ARTHROFIBROSIS. THE COMPLAINT ALLEGATION WAS NOT CONFIRMED. NO EVIDENCE OF THAT FAILURE WAS RECEIVED.

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 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. ON (B)(6) 2018, PATIENT PRESENTED WITH INCREASED PAIN FOLLOWING ¿AN INCIDENT WHEN SHE GOT OUT OF BED AND IRRITATED HER KNEE¿. PATIENT ALSO REPORTED THAT SHE WAS DOING WELL, UNTIL SHE FELT A POP IN PHYSICAL THERAPY, AND HAS HAD PAIN SINCE. RADIOGRAPHS WERE OBTAINED; RADIOGRAPH REVIEW SHOWED LATERAL COMPARTMENT ARTHROSIS, BUT NO OTHER CHANGES OR INJURIES WERE NOTED. IT WAS REPORTED THAT UPON EVALUATION, RANGE OF MOTION WAS VERY GOOD, AND SOME INFLAMMATION WAS PRESENT. PATIENT WAS STARTED ON A MEDROL DOSEPAK AND CONTINUED ON DICLOFENAC. PATIENT WAS STARTED ON PERCOCET AS OTHER PAIN MEDICATION WAS NOT HELPING. PHYSICAL THERAPY WAS PUT ON HOLD. ON (B)(6) 2018 FOLLOW-UP VISIT, PATIENT PRESENTED WITH CONTINUED PAIN AND SWELLING. ON (B)(6) 2019 FOLLOW-UP VISIT, PATIENT PRESENTED WITH WORSENING PAIN, STIFFNESS, AND NUMBNESS/TINGLING. IT WAS NOTED THAT THE PATIENT HAD DEVELOPED LATERAL ARTHRITIS WITH VALGUS DEFORMITY. DUE TO FAILED UNICOMPARTMENTAL KNEE ARTHROPLASTY, PATIENT UNDERWENT REVISION SURGERY ON (B)(6) 2019.