BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LOGIC CR TIB INSERT SLOPE ++, SZ 2.5, 9 MM

    MDR report key: 17044542 · Received June 1, 2023

    Report

    Report Number
    1038671-2023-01209
    Event Type
    Injury
    Date Received
    June 1, 2023
    Date of Event
    May 2, 2023
    Report Date
    August 23, 2023
    Manufacturer
    EXACTECH, INC.
    Product Code
    JWH
    UDI-DI
    10885862159212
    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

    H3: THE REVISION REPORTED WAS LIKELY THE RESULT OF PROSTHESIS WEAR OF THE TIBIAL INSERT AND PATELLA POSSIBLY DUE TO MALALIGNMENT BETWEEN THE IMPLANTS, HIGH CONTACT STRESSES DURING KNEE FLEXION/EXTENSION, THIRD BODY WEAR, PATIENT-RELATED CONDITIONS, INSTABILITY, OR ANY COMBINATION OF THESE POSSIBILITIES. THE CAUSE OF THE PROSTHESIS WEAR CANNOT BE DETERMINED BECAUSE MINIMAL INFORMATION WAS PROVIDED, THE REVISED COMPONENTS WERE NOT RETURNED FOR EVALUATION, AND NO INITIAL POST-OPERATIVE RADIOGRAPHS WERE PROVIDED.

    Additional Manufacturer Narrative · 0

    PENDING INVESTIGATION. D10: 4839357 02-010-04-0325 - LOGIC CR FEMORAL POR, RIGHT, SZ 2.5. 5500300 02-012-45-2525 - LGC TIBIAL FIT TRAY CEM SZ 2.5F / 5T. CREDIT TO LOGIC 200-00-00 - KNEE ITEM-MISC. 4855281 200-02-35 - THREE PEG PATELLA 35MM. 5501119 201-78-15 - HOLDING PIN MINI SHARP POINT 4 PK. 5446937 201-78-81 - 3 TROCAR, MOD. HEX 2PK. 5410044 521-78-23 - THREADED PIN SIZE 2.3 COLLARED. 5410045 521-78-23 - THREADED PIN SIZE 2.3 COLLARED. 5410065 521-78-32 - THREADED PIN SIZE 3.0 COLLARLESS. 6035018122 A10012 - GPS IMPLANT KIT V2. H7: Z-0021-2022.

    Description of Event or Problem · 0

    AS REPORTED, THE PATIENT HAD AN INITIAL RIGHT TKA ON (B)(6) 2018. THE PATIENT'S LINER AND PATELLA WERE REVISED ON (B)(6) 2023 DUE TO POLY WEAR. 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
    2289338 LOGIC CR TIB INSERT SLOPE ++, SZ 2.5, 9 MM PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED JWH EXACTECH, INC. 02-012-49-2509 10885862159212

    Patients

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