BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LOGIC CR TIB INSERT STD, SZ 5, 11MM

    MDR report key: 23509672 · Received November 10, 2025

    Report

    Report Number
    1038671-2025-03299
    Event Type
    Injury
    Date Received
    November 10, 2025
    Date of Event
    October 9, 2025
    Report Date
    November 10, 2025
    Manufacturer
    EXACTECH, INC.
    Product Code
    JWH
    PMA / PMN Number
    K111400
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    D10: 200-02-32 THREE PEG PATELLA 32MM: SN# (B)(6). 02-010-03-0350 - LOGIC CR FEMORAL CEM, RIGHT, SZ 5: SN# (B)(6). 02-012-45-5050 - LGC TIBIAL FIT TRAY CEM SZ 5F / 5T: SN# (B)(6). THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS; HOWEVER, AN INVESTIGATION OF THE REPORTED EVENT IS IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETED, A SUPPLEMENTAL MEDWATCH 3500A WILL BE SUBMITTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL TOTAL KNEE REPLACEMENT ON THE LEFT SIDE. SUBSEQUENTLY, THE PATIENT EXPERIENCED POLYETHYLENE WEAR, SYNOVITIS, INFLAMMATION, PAIN, LOSS OF RANGE OF MOTION AND DISSATISFACTION WITH THEIR LEFT TOTAL KNEE. AS A RESULT, APPROXIMATELY NINE YEARS AND FOUR MONTHS POST-SURGERY, THE PATIENT UNDERWENT A REVISION. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. NO FURTHER IMPACT TO THE PATIENT WAS REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME. THIS IS REPORT 1 OF 2 FOR THIS EVENT/PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2543292 LOGIC CR TIB INSERT STD, SZ 5, 11MM PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL JWH EXACTECH, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Male Hospitalization SEE H11.