BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OPTETRAK LOGIC

    MDR report key: 16869478 · Received May 4, 2023

    Report

    Report Number
    1038671-2023-00904
    Event Type
    Injury
    Date Received
    May 4, 2023
    Date of Event
    January 1, 2016
    Report Date
    March 3, 2026
    Manufacturer
    EXACTECH, INC.
    Product Code
    JWH
    UDI-DI
    10885862001740
    PMA / PMN Number
    K033883
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    D10. CONCOMITANTS: 02-010-06-0220 FEMORAL COMPONENT. 02-012-45-2020 TIBIAL TRAY . 204-34-04 TIBIAL STEM EXTENSION . 02-012-60-1412 STEM EXTENSION.

    Description of Event or Problem · 0

    IT WAS REPORTED POST-OP VIA CLINICAL STUDY THAT THE 53 YO FEMALE EXPERIENCE REFLEX SYMPATHETIC DYSTROPHY, CAUSING EXTREME HYPERSENSITIVITY FROM MID-THIGH TO FOOT. THE DATE OF EVENT ONSET IS UNK-UNK-2016. THE PATIENT WAS TREATED WITH MEDICATION AND REFERRED TO PAIN MANAGEMENT. THE OUTCOME WAS LAST KNOWN AS RESOLVED ON (B)(6) 2017.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    859496 OPTETRAK LOGIC PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED JWH EXACTECH, INC. UNK UNK 10885862001740

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Female Other| R