BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LOGIC CR TIB INSERT SLOPE+, SZ 4, 9MM

    MDR report key: 18086375 · Received November 7, 2023

    Report

    Report Number
    1038671-2023-02708
    Event Type
    Injury
    Date Received
    November 7, 2023
    Date of Event
    March 7, 2023
    Report Date
    November 30, 2023
    Manufacturer
    EXACTECH, INC.
    Product Code
    JWH
    UDI-DI
    10885862174482
    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 PROSTHESIS FRACTURE. 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. ADDITIONALLY, A CONTRIBUTING FACTOR TO THE SEVERE WEAR AND DELAMINATION MAY HAVE BEEN THE RESULT OF BEING PACKAGED IN A NON-CONFORMING VACUUM BAG FOR MORE THAN FIVE YEARS. THE EXTENT AND ROOT CAUSE OF THE PROSTHESIS WEAR AND PROSTHESIS FRACTURE COULD NOT BE DETERMINED AS THE DEVICES WERE NOT RETURNED FOR EVALUATION, AND RADIOGRAPHS WERE NOT PROVIDED.

    Additional Manufacturer Narrative · 0

    H3: PENDING INVESTIGATION. D10: 5864966 02-010-04-0240 LOGIC CR FEMORAL POR, LEFT, SZ 4, 4948944 02-012-45-4050 LGC TIBIAL FIT TRAY CEM SZ 4F / 5T, 5747422 200-02-41 THREE PEG PATELLA 41MM. 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. REVISED FROM CR TO PS. THE FEMORAL COMPONENT AND LINER WERE 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
    350435 LOGIC CR TIB INSERT SLOPE+, SZ 4, 9MM PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL JWH EXACTECH, INC. 10885862174482

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Required Intervention SEE H10