BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OPTETRAK LOGIC

    MDR report key: 16628493 · Received March 28, 2023

    Report

    Report Number
    1038671-2023-00523
    Event Type
    Injury
    Date Received
    March 28, 2023
    Date of Event
    February 11, 2020
    Report Date
    April 15, 2026
    Manufacturer
    EXACTECH, INC.
    Product Code
    JWH
    UDI-DI
    10885862266040
    PMA / PMN Number
    K150890
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CONCOMITANTS: 5126729, 02-010-06-0330 - LOGIC CC FEMORAL SIZE 3, RIGHT; 5022435, 02-010-06-0531 - LOGIC POST. AUG. BLOCK SIZE 3, 5MM; 4862759, 02-010-66-1002 - METAPHYSEAL FEMORAL CONE, SMALL, H42MM; 4805607, 02-012-60-1480 - LOGIC STEM EXT 14MM X 80MM; 4996490, 02-012-60-1612 - LOGIC STEM EXT 16MM X 120MM; 5091481, 02-012-66-1000 - METAPHYSEAL TIBIAL CONE, ML29MM; 5248399, 02-022-45-3020 - TRULIANT TIB FIT TRAY CEM SZ 3F / 2T; 4941793, 200-02-35 - THREE PEG PATELLA 35MM; 5147204, 208-05-03 - CC DISTAL FEM AUGMENT SZ 3, 5MM; 5050368, 208-06-03 - CC DISTAL FEM AUGMENT SZ 3, 10MM; 5050384, 208-06-03 - CC DISTAL FEM AUGMENT SZ 3, 10MM.

    Description of Event or Problem · 0

    IT WAS REPORTED VIA CLINICAL STUDY, THAT THE 69 YO FEMALE PATIENT CAUGHT AN INFECTION. THE DATE OF ADVERSE EVENT ONSET IS UNK-UNK-UNK. THE INITIAL SURGERY DATE WAS ON 02-20-2018. THE PATIENT WAS REVISED WITH EXACTECH COMPONENTS (POLY EXCHANGE) ON 02-11-2020. THE PATIENT¿S OUTCOME WAS LAST KNOWN AS RESOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    479770 OPTETRAK LOGIC PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED JWH EXACTECH, INC. UNK UNK 10885862266040

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Female Required Intervention| O