BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LOGIC TIB INSERT IMPL CRC, SZ 5, 9MM

    MDR report key: 17368336 · Received July 20, 2023

    Report

    Report Number
    1038671-2023-01737
    Event Type
    Injury
    Date Received
    July 20, 2023
    Date of Event
    July 3, 2023
    Report Date
    December 15, 2023
    Manufacturer
    EXACTECH, INC.
    Product Code
    JWH
    UDI-DI
    10885862230560
    PMA / PMN Number
    K123342
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PENDING INVESTIGATION. D10: THREE PEG PATELLA 38MM - 200-02-38 -(B)(6) LGC TIBIAL FIT TRAY CEM SZ 5F / 5T - 02-012-45-5050 - (B)(6), LOGIC CR FEMORAL POR, LEFT, SZ 5 - 02-010-04-0250 - (B)(6), THREE PEG PATELLA 41MM - 200-02-41 - (B)(6), LOGIC CR FEMORAL CEM, RIGHT, SZ 5 - 02-010-03-0350 - (B)(6), LOGIC TIB INSERT IMPL CRC, SZ 5, 9MM - 02-012-51-5009 - (B)(6), LGC TIBIAL FIT TRAY CEM SZ 5F / 5T - 02-012-45-5050 - (B)(6). H7: Z-0021-2022.

    Additional Manufacturer Narrative · 0

    H3: BASED ON REVIEW OF ALL AVAILABLE INFORMATION, THERE IS NO EVIDENCE TO SUGGEST THAT THE REPORTED EVENT IS RELATED TO ANY DESIGN OR MANUFACTURING ISSUES; NO DEVICE INFORMATION WAS PROVIDED. THE CAUSE OF THE PATIENT¿S INFECTION AND SUBSEQUENT REVISION CANNOT BE CONCLUSIVELY DETERMINED; HOWEVER, IT IS MOST LIKELY RELATED TO THE PATIENT¿S UNDERLYING CONDITION AS ASSOCIATED WITH THE INTERACTION BETWEEN THE IMPLANTED DEVICE AND THE PATIENT DUE TO PATIENT ILLNESS, UNIQUE ANATOMY, OR OTHER CONDITION THAT IMPACTS THE PERFORMANCE OF THE DEVICE. THESE DEVICES ARE USED FOR TREATMENT NOT DIAGNOSIS.

    Description of Event or Problem · 0

    AS REPORTED, THIS IS THE 3RD REVISION FOR THIS PATIENT'S RIGHT KNEE. THE POLY LINER WAS EXCHANGED TWICE BEFORE DUE TO WEAR. AS MULTIPLE REVISION SURGERIES WERE DONE UNFORTUNATELY RISK INCREASES. THE PATIENT WAS REVISED ON (B)(6) 2023 DUE TO INFECTION. A NEW FEMORAL COMPONENT AND LINER WERE IMPLANTED. CEMENT WAS UTILIZED FOR TIBIA AND PATELLA. 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. NO OTHER PATIENT INFORMATION / MEDICAL HISTORY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2107528 LOGIC TIB INSERT IMPL CRC, SZ 5, 9MM PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED JWH EXACTECH, INC. 02-012-51-5009 10885862230560

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Male Required Intervention SEE H10