BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LOGIC TIBIA PS MOD INSRT SZ 3 9MM

    MDR report key: 17318123 · Received July 13, 2023

    Report

    Report Number
    1038671-2023-01648
    Event Type
    Injury
    Date Received
    July 13, 2023
    Date of Event
    September 25, 2021
    Report Date
    July 25, 2025
    Manufacturer
    EXACTECH, INC.
    Product Code
    JWH
    UDI-DI
    10885862001801
    PMA / PMN Number
    K033883
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    SECTION H10: (H3) PENDING EVALUATION (D10) CONCOMITANT DEVICE(S): 1890191 02-010-01-0330 - LOGIC FEMORAL PS CEM RIGHT SZ 3. 1723312 02-012-39-3030 - LOGIC TIBIA FIN TRAY CEM SZ 3F/3T. 1684451 200-02-35 - THREE PEG PATELLA 35MM.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL AND/OR CORRECTED INFORMATION. THE REASON FOR THE REPORTED REVISION CANNOT BE CONFIRMED FROM THE INFORMATION PROVIDED BUT MAY BE DUE TO INCLUSION OF THE POLYETHYLENE IN THE PACKAGING RECALL, WEAR, LOOSENING, INFECTION, FRACTURE, INSTABILITY, AND/OR PATIENT RELATED FACTORS. POTENTIAL CONTRIBUTIONS OF USER OR PATIENT-RELATED CONSIDERATIONS TO THE EVENT COULD NOT BE ASSESSED AS THE DEVICES WERE NOT AVAILABLE FOR EVALUATION AND RELEVANT CLINICAL INFORMATION, IMAGES, OR RADIOGRAPHS WERE NOT PROVIDED. IF ANY FURTHER INFORMATION IS OBTAINED THAT WOULD CHANGE OR ALTER ANY INFORMATION PROVIDED, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THIS PATIENT'S RIGHT KNEE WAS REVISED APPROXIMATELY 10.5 YEARS POST OP. REASON FOR THE REVISION IS UNKNOWN. INFORMATION ON EVENT WAS FOUND WHEN AN INCORRECT PART FOR A DIFFERENT CASE WAS RECEIVED ((B)(4)) NO ADDITIONAL INFORMATION WAS PROVIDED OR FOUND.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    312247 LOGIC TIBIA PS MOD INSRT SZ 3 9MM PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL JWH EXACTECH, INC. 02-012-35-3009 UNK 10885862001801

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown SEE H10