BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LOGIC CR TIB INSERT STD, SZ 5, 9MM

    MDR report key: 18197019 · Received November 22, 2023

    Report

    Report Number
    1038671-2023-02852
    Event Type
    Injury
    Date Received
    November 22, 2023
    Date of Event
    November 2, 2023
    Report Date
    November 21, 2024
    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

    H3: THE REVISION REPORTED WAS LIKELY THE RESULT OF PROSTHESIS WEAR AND AN INSUFFICIENT BOND BETWEEN THE FEMORAL COMPONENT AND THE BONE, WHICH LED TO ASEPTIC (NON-INFECTED) FEMORAL LOOSENING. POSSIBLE CAUSES FOR POLYETHYLENE WEAR INCLUDE MALALIGNMENT BETWEEN THE IMPLANTS, HIGH CONTACT STRESSES DURING KNEE FLEXION, THIRD BODY WEAR, PATIENT-RELATED CONDITIONS, INSTABILITY, OR ANY COMBINATION OF THESE POSSIBILITIES. THE EXTENT AND ROOT CAUSE OF THE PROSTHESIS WEAR AND FEMORAL LOOSENING COULD NOT BE DETERMINED AS THE DEVICES WERE NOT RETURNED FOR EVALUATION, AND RADIOGRAPHS WERE NOT PROVIDED.

    Additional Manufacturer Narrative · 0

    CORRECTION: H6 CLINICAL CODE, H6 COMPONENT CODE, H6 INVESTIGATION FINDINGS, H6 INVESTIGATION CONCLUSIONS.

    Additional Manufacturer Narrative · 0

    CORRECTION: H6 TYPE OF INVESTIGATION.

    Additional Manufacturer Narrative · 0

    H3: PENDING INVESTIGATION. D10: 3879987 - 02-010-04-0250 - LOGIC CR FEMORAL POR, LEFT, SZ 5 5828984 - 02-012-45-5050 - LGC TIBIAL FIT TRAY CEM SZ 5F / 5T 5893473 - 200-02-38 - THREE PEG PATELLA 38MM 5967715 - 201-78-15 - HOLDING PIN MINI SHARP POINT 4 PK 4923884 - 201-78-81 - 3 TROCAR, MOD. HEX 2PK S017624 - 521-78-23 - THREADED PIN SIZE 2.3 COLLARED S017625 - 521-78-23 - THREADED PIN SIZE 2.3 COLLARED S013348 - 521-78-32 - THREADED PIN SIZE 3.0 COLLARLESS 3042019052 - A10012 - GPS IMPLANT KIT V2 H7: Z-0021-2022.

    Description of Event or Problem · 0

    AS REPORTED, THE PATIENT HAD AN INITIAL LEFT TKA ON (B)(6) 2019. THE PATIENT WAS REVISED ON (B)(6) 2023 DUE TO POLY WEAR AND FEMUR LOOSENING. 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
    2041285 LOGIC CR TIB INSERT STD, SZ 5, 9MM PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL JWH EXACTECH, INC. 10885862174543

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Male Required Intervention SEE H10.