BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LOGIC CR TIB INSERT STD, SZ 5, 9MM

    MDR report key: 17177549 · Received June 21, 2023

    Report

    Report Number
    1038671-2023-01432
    Event Type
    Injury
    Date Received
    June 21, 2023
    Date of Event
    May 23, 2023
    Report Date
    August 24, 2023
    Manufacturer
    EXACTECH, INC.
    Product Code
    JWH
    UDI-DI
    10885862174543
    PMA / PMN Number
    K111400
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PENDING INVESTIGATION. D10: 5241147; 02-010-04-0350 - LOGIC CR FEMORAL POR, RIGHT, SZ 5. 3659550; 02-012-45-5060 - LGC TIBIAL FIT TRAY CEM SZ 5F / 6T. 6547555; 200-02-41 - THREE PEG PATELLA 41MM. H7: Z-0021-2022.

    Additional Manufacturer Narrative · 0

    H3: THE REVISION REPORTED WAS LIKELY THE RESULT OF PRESUMED PROSTHESIS WEAR OF THE TIBIAL INSERT. HOWEVER, IMAGES OF THE REVISED INSERT DO NOT SHOW SIGNS OF EXCESSIVE PROSTHESIS WEAR INCONSISTENT WITH BEING IMPLANTED, NO RADIOGRAPHS WERE PROVIDED, AND THE REVISED COMPONENT WAS NOT RETURNED TO EXACTECH FOR EVALUATION. ADDITIONALLY, A CONTRIBUTING FACTOR TO THE CONCERN FOR POSSIBLE WEAR MAY HAVE BEEN THE RESULT OF THE INSERT BEING PACKAGED IN A NON-CONFORMING VACUUM BAG FOR MORE THAN FIVE YEARS.

    Description of Event or Problem · 0

    AS REPORTED, THE PATIENT HAD AN INITIAL RIGHT TKA ON (B)(6) 2021. THE PATIENT WAS REVISED ON (B)(6) 2023 DUE TO POLY WEAR AND THE LINER WAS EXCHANGED. THERE WAS NO REPORTED BREAKAGE OF A DEVICE OR SURGICAL DELAY/PROLONGATION. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    62393 LOGIC CR TIB INSERT STD, SZ 5, 9MM PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED JWH EXACTECH, INC. 02-012-47-5009 10885862174543

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Male Required Intervention SEE H10.