UNK

Additional Manufacturer Narrative

ADDITIONAL INFORMATION: G3, H3, H6. BASED ON THE INFORMATION PROVIDED WHICH MAY INCLUDE THE DEVICE (IF AVAILABLE AND RETURNED), PICTURES, VIDEOS, EVENT DESCRIPTION, AND ANY ADDITIONAL INFORMATION FROM THE FIELD, ARTHREX WAS ABLE TO CONCLUDE A MOST LIKELY CAUSE. THE MOST LIKELY CAUSE FOR THE REPORTED FAILURE CAN BE ATTRIBUTED TO A PATIENT-SPECIFIC EVENT. IT IS NOT STATED WHETHER OR NOT THE PATIENT FOLLOWED THE CORRECT POST-OP PROCEDURES OR NOT.

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 BY THE ARTHREX CLINICAL RESEARCH TEAM VIA EMAIL THAT WHILE REVIEWING A CLINICAL STUDY, IT WAS NOTED ON (B)(6) 2024 A PATIENT PRESENTED FOR EVALUATION OF LEFT KNEE PAIN. THE PATIENT HAD A LEFT MEDIAL UNICOMPARTMENTAL KNEE ARTHROPLASTY UTILIZING THE IBALANCE UKA IN 2018 AND HAS DONE VERY WELL UNTIL RECENTLY EXPERIENCING SOME NEW ONSET AND WORSENING LATERAL KNEE PAIN, DESCRIBED AS DULL, ACHING, AND THROBBING AT TIMES. THE HEALTHCARE PROVIDER REPORTS THE RADIOGRAPHS SHOW THE MEDIAL UNICOMPARTMENTAL ARTHROPLASTY IN GOOD POSITION WITHOUT SIGNS OF LOOSENING OR COMPLICATION, AND PROGRESSION OF ARTHRITIS ESPECIALLY IN THE LATERAL COMPARTMENT AND PATELLOFEMORAL COMPARTMENT AS COMPARED TO PRIOR RADIOGRAPHS FROM 2018. THERE IS NEARLY BONE-ON-BONE "JOINT SPACE ROWING" IN THE LATERAL COMPARTMENT. THE HEALTHCARE PROVIDER DETERMINED THE DEFINITIVE TREATMENT FOR THIS ISSUE WOULD BE A CONVERSION TO A TOTAL KNEE ARTHROPLASTY. (B)(6) 2024 X-RAYS SHOW MEDIAL UKA COMPONENTS IN PROPER POSITION: MODERATE TO ADVANCED DEGENERATIVE CHANGES OF THE LATERAL PATELLOFEMORAL JOINT SPACES WITH NEAR BONE-ON-BONE AND PERIARTICULAR OSTEOPHYTE FORMATION. A REVISION WAS PERFORMED ON (B)(6) 2024 FOR ADJACENT COMPARTMENT OSTEOARTHRITIS.