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 (B)(6) 2025 IT WAS REPORTED BY THE ARTHREX CLINICAL RESEARCH TEAM VIA EMAIL THAT WHILE REVIEWING A CLINICAL STUDY, A PATIENT WITH A HISTORY OF LEFT MEDIAL COMPARTMENT UNICOMPARTMENTAL ARTHROPLASTY APPROXIMATELY 6 YEARS AGO UTILIZING THE IBALANCE UKA DEVELOPED SOME LATERAL SIDED PAIN AND CATCHING AND CLICKING ON THE LATERAL SIDE WITH FLEXION AND EXTENSION. CRAMPING PAIN IN THE LOWER LEG AND SHOOTING PAIN INTO THE FOOT IS ALSO PRESENT. PER THE HEALTHCARE PROVIDER, X-RAYS DEMONSTRATE RATHER SIGNIFICANT LATERAL COMPARTMENT CHANGES, AND SOME OF THE PAIN AND MECHANICAL SYMPTOMS CERTAINLY COULD BE RELATED TO ONGOING DEGENERATIVE CHANGE ON THE LATERAL SIDE OF THE KNEE. ON (B)(6) 2025 DEVICES WERE EXPLANTED DUE TO A FAILED UKA.

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 EVENT. SOME OF THE REPORTED PAIN AND MECHANICAL SYMPTOMS COULD BE ASSOCIATED WITH ONGOING DEGENERATIVE CHANGES ON THE LATERAL SIDE OF THE KNEE. THE COMPLAINT ALLEGATION WAS NOT CONFIRMED. NO EVIDENCE OF THAT FAILURE WAS RECEIVED.