BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LOGIC FEMORAL PS CEM RIGHT SZ 3

    MDR report key: 19296367 · Received May 13, 2024

    Report

    Report Number
    1038671-2024-01190
    Event Type
    Injury
    Date Received
    May 13, 2024
    Date of Event
    April 22, 2024
    Report Date
    December 16, 2024
    Manufacturer
    EXACTECH, INC.
    Product Code
    JWH
    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): 2013998, 02-012-35-3015 - LOGIC TIBIA PS MOD INSRT SZ 3 15MM, 2025335, 02-012-45-3020 - LGC TIBIAL FIT TRAY CEM SZ 3F / 2T, 2184803, 200-02-32 - THREE PEG PATELLA 32MM, 2191764, 02-012-45-3020 - LGC TIBIAL FIT TRAY CEM SZ 3F / 2T, 2195603, 02-010-01-0330 - LOGIC FEMORAL PS CEM RIGHT SZ 3 ,2223753, 200-02-32 - THREE PEG PATELLA 32MM, 2238446, 02-010-01-0230 - LOGIC FEMORAL PS CEM LEFT SZ 3.

    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 AN INSUFFICIENT BOND BETWEEN THE FEMORAL COMPONENT AND BONE WHICH LED TO ASEPTIC (NON-INFECTED) FEMORAL LOOSENING AND PAIN AFTER 12 YEARS OF IMPLANTATION. HOWEVER, POTENTIAL CONTRIBUTIONS FROM PROSTHESIS WEAR, AND/OR PATIENT-RELATED CONDITIONS TO THE REPORTED EVENT CANNOT BE CONFIRMED AS THE DEVICES WERE NOT AVAILABLE FOR EVALUATION AND LIMITED INFORMATION WAS 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 63 Y/O FEMALE PATIENT'S RIGHT KNEE WAS REVISED APPROXIMATELY 12 YEARS POST OP INITIAL SURGERY. PATIENT COMPLAINED OF PAIN. LOOSE FEMUR AND RECALLED POLY. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. DEVICES ARE NOT RETURNING, DUE TO RECALL HOSPITAL WILL NOT RELEASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    449296 LOGIC FEMORAL PS CEM RIGHT SZ 3 PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL JWH EXACTECH, INC. UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Female Required Intervention SEE H10