BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LOGIC CR TIB INSERT STD, SZ 2.5, 9 MM

    MDR report key: 24079684 · Received January 15, 2026

    Report

    Report Number
    1038671-2026-00050
    Event Type
    Injury
    Date Received
    January 15, 2026
    Date of Event
    February 29, 2024
    Report Date
    January 15, 2026
    Manufacturer
    EXACTECH, INC.
    Product Code
    JWH
    UDI-DI
    10885862159144
    PMA / PMN Number
    K111400
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CONCOMITANTS -D10: 3905981 - 02-010-03-0225 - LOGIC CR FEMORAL CEM, LEFT SZ 2.5. 3806919 - 02-012-45-2525 - LGC TIBIAL FIT TRAY CEM SZ 2.5F / 2.5T. 3888001 - 200-02-35 - THREE PEG PATELLA 35MM. 3870852 - 201-46-10 - HOLDING PIN HEADLESS 3." THE REVISION REPORTED WAS LIKELY THE RESULT OF SWELLING AND SYNOVITIS. LOCALIZED PROSTHESIS WEAR WAS NOTED ON THE IMAGE OF THE TIBIAL INSERT, BUT IT CANNOT BE DETERMINED IF THIS CONTRIBUTED TO THE SYNOVITIS, SWELLING, AND/OR REASON FOR THE REVISION. THE REASON FOR THE SWELLING AND SYNOVITIS CANNOT BE CONCLUSIVELY DETERMINED BECAUSE THE DEVICE WAS NOT RETURNED FOR EVALUATION AND RELEVANT PATIENT INFORMATION WAS NOT PROVIDED. SHOULD ADDITIONAL RELEVANT INFORMATION BE OBTAINED, A FOLLOW-UP MDR WILL BE SUBMITTED ACCORDINGLY.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT, INITIAL LEFT KNEE IMPLANTED AND THEN UNDERWENT A REVISION PROCEDURE, APPROXIMATELY 8 YEARS 10 MONTHS POST THE INITIAL PROCEDURE. THE PATIENT WAS REVISED DUE TO SYNOVITIS AND SWELLING TO A NEW SIZE 9 INSERT. THERE WERE NO ISSUES WITH SURGERY. THE EXPLANTS ARE NOT AVAILABLE FOR RETURN. X-RAYS AND DEVICE IMAGES WERE PROVIDED. NO FURTHER INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    147050 LOGIC CR TIB INSERT STD, SZ 2.5, 9 MM PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL JWH EXACTECH, INC. 10885862159144

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Hospitalization| R SEE H11.