BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LOGIC FEMORAL PS CEM RIGHT SZ 3.5

    MDR report key: 17097082 · Received June 9, 2023

    Report

    Report Number
    1038671-2023-01303
    Event Type
    Injury
    Date Received
    June 9, 2023
    Date of Event
    May 9, 2023
    Report Date
    March 6, 2025
    Manufacturer
    EXACTECH, INC.
    Product Code
    JWH
    UDI-DI
    10885862001245
    PMA / PMN Number
    K093360
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ME, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    SECTION H10: (H3) PENDING EVALUATION: (D10) CONCOMITANT DEVICE(S): 02-012-35-3509, 2982063 - LOGIC TIBIA PS MOD INSRT SZ 3.5, 9MM. 02-012-45-3535, 2579814 - LOGIC TIBIAL FIT TRAY CEM 3.5F/3.5T. 200-02-35, 2551741 - THREE PEG PATELLA 35MM.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL AND/OR CORRECTED INFORMATION. THE REVISION REPORTED WAS LIKELY THE RESULT OF FEMORAL LOOSENING. POTENTIAL CONTRIBUTIONS OF USER AND PATIENT-RELATED CONSIDERATIONS TO THE EVENT COULD NOT BE ASSESSED AS THE DEVICES WERE NOT AVAILABLE FOR EVALUATION AND IMAGES 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

    AS REPORTED, APPROXIMATELY 5 YEARS POST OP INITIAL RIGHT TKA, THIS MALE PATIENT WAS REVISED DUE TO SEVERE OSTEOLYSIS NOTED ON X-RAYS. FEMORAL COMPONENTS WERE LOOSE ONCE DISSECTION WAS COMPLETED. ALL COMPONENTS WERE SUBSEQUENTLY REMOVED AND REPLACED WITH COMPETITORS COMPONENTS. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. DEVICES ARE NOT RETURNING- HOSPITAL POLICY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    493982 LOGIC FEMORAL PS CEM RIGHT SZ 3.5 PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL JWH EXACTECH, INC. UNK UNK 10885862001245

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male