BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LOGIC CR TIB INSERT STD, SZ 2.5, 9 MM

    MDR report key: 16028887 · Received December 21, 2022

    Report

    Report Number
    1038671-2022-01618
    Event Type
    Injury
    Date Received
    December 21, 2022
    Date of Event
    December 7, 2022
    Report Date
    October 2, 2025
    Manufacturer
    EXACTECH, INC.
    Product Code
    JWH
    UDI-DI
    10885862159144
    PMA / PMN Number
    K111400
    Removal / Correction Number
    Z-0021-2022
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DEVICE EVALUATED BY MFR: BASED ON REVIEW OF ALL AVAILABLE INFORMATION, THERE IS NO EVIDENCE TO SUGGEST THAT THE REPORTED EVENT IS RELATED TO ANY DESIGN ISSUES. THE CAUSE OF INSTABILITY AND THE SUBSEQUENT REVISION CANNOT BE CONCLUSIVELY DETERMINED; HOWEVER, IT IS MOST LIKELY RELATED TO PATIENT CONDITIONS AS ASSOCIATED WITH THE INTERACTION BETWEEN THE IMPLANTED DEVICE AND THE PATIENT DUE TO PATIENT ILLNESS, UNIQUE ANATOMY, OR OTHER CONDITION THAT IMPACTS THE PERFORMANCE OF THE DEVICE. THESE DEVICES ARE USED FOR TREATMENT NOT DIAGNOSIS. CONCOMITANT MEDICAL PRODUCTS: 02-012-45-2525, 4313238 - LGC TIBIAL FIT TRAY CEM SZ 2.5F / 2.5T, 02-010-04-0325, 4122408 - LOGIC CR FEMORAL POR, RIGHT, SZ 2.5, 200-02-35, 6083463 - THREE PEG PATELLA, 35MM.

    Description of Event or Problem · 0

    AS REPORTED, APPROXIMATELY 2.5 YEARS POST OP THE INITIAL RIGHT TKA, THIS 84 Y/O FEMALE PATIENT WAS REVISED DUE TO INSTABILITY. THE PATIENT WAS REVISED TO EXACTECH DEVICES. THERE WERE NO REPORTED ISSUES DURING THE REVISION PROCEDURE. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. NO OTHER PATIENT INFORMATION//MEDICAL HISTORY REPORTED. DEVICES WILL NOT BE RETUNING; DISPOSED OF BY HOSPITAL. NO ADDITIONAL INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1650521 LOGIC CR TIB INSERT STD, SZ 2.5, 9 MM PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL JWH EXACTECH, INC. 02-012-47-2509 UNK 10885862159144

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Female Required Intervention SEE H10.