BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LOGIC TIBIA IMPLANT PSC INSERT, SZ 3, 15MM

    MDR report key: 24114344 · Received January 20, 2026

    Report

    Report Number
    1038671-2026-00057
    Event Type
    Injury
    Date Received
    January 20, 2026
    Report Date
    January 20, 2026
    Manufacturer
    EXACTECH, INC.
    Product Code
    JWH
    UDI-DI
    10885862173584
    PMA / PMN Number
    K110547
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    D10: 02-012-60-1612 - TRU STEM EXT 16MM X 120MM: (B)(6). 208-05-03 - CC DISTAL FEM AUGMENT SZ 3, 5MM: (B)(6). 208-05-03 - CC DISTAL FEM AUGMENT SZ 3, 5MM: (B)(6). 02-010-06-0230 - TRU CC FEMORAL SIZE 3 LEFT: (B)(6). 02-010-06-0531 - TRU POST. AUG. SIZE 3, 5MM: (B)(6). 02-010-06-0531 - TRU POST. AUG. SIZE 3, 5MM: (B)(6). THE REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. NO DEVICE WAS RETURNED FOR EVALUATION; FURTHER, PHOTOGRAPHS AND/OR RADIOGRAPH IMAGES WERE NOT PROVIDED FOR REVIEW. OPERATIVE NOTES AND/OR MEDICAL RECORDS WERE NOT PROVIDED FOR REVIEW OF USAGE/TECHNIQUE. A DEFINITIVE ROOT CAUSE WAS UNABLE TO BE DETERMINED AS THE NECESSARY INFORMATION TO ADEQUATELY INVESTIGATE THE REPORTED EVENT WAS NOT PROVIDED. IF ANY FURTHER INFORMATION IS OBTAINED THAT WOULD CHANGE OR ALTER ANY INFORMATION PROVIDED, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY.

    Description of Event or Problem · 0

    IT WAS REPORTED THE PATIENT UNDERWENT A LEFT KNEE REVISION APPROXIMATELY SEVEN AND A HALF (7.5) YEARS AGO AND ALLEGES THAT THEY WILL NEED ANOTHER REVISION PROCEDURE DUE TO PROSTHESIS WEAR. IT IS UNKNOWN IF A REVISION HAS BEEN PLANNED. NO SURGICAL OR MEDICAL INTERVENTIONS WERE REPORTED. NO PATIENT IMPACT WAS REPORTED. NO OTHER INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    181489 LOGIC TIBIA IMPLANT PSC INSERT, SZ 3, 15MM PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL JWH EXACTECH, INC. 10885862173584

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Other SEE H11.