BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HYPROCURE

    MDR report key: 11852033 · Received May 19, 2021

    Report

    Report Number
    3004993707-2021-00022
    Event Type
    Injury
    Date Received
    May 19, 2021
    Date of Event
    December 19, 2016
    Report Date
    April 12, 2021
    Manufacturer
    GRAHAM MEDICAL TECHNOLOGIES, LLC. DBA GRAMEDICA
    Product Code
    HWC
    UDI-DI
    M621HYP070
    PMA / PMN Number
    K042030
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A MULTICENTER POST MARKET CLINICAL FOLLOW-UP RETROSPECTIVE STUDY IS BEING PERFORMED AT SPECIFIC TIME POINTS POST-IMPLANTATION TO EVALUATE THE SAFETY AND PERFORMANCE OF THE HYPROCURE IMPLANT. THE PMCF STUDIES WERE NOT REQUESTED BY FDA. THE MANUFACTURER WAS NOT MADE AWARE OF THESE ISSUES PRIOR TO THE REPORT STUDY AND NO COMPLAINTS HAVE BEEN MADE. THE PATIENT HAD THE DEVICE REMOVED AND HAS SINCE BEEN HAVING ISSUES READJUSTING HER GAIT DUE TO MISALIGNMENT.

    Description of Event or Problem · 1

    READJUSTING MY GAIT AFTER REMOVAL, AS I HAD A LIMP AND MISALIGNMENT IN MY LEFT HIP. (THE DEVICE LIMITED MOBILITY IN MY RIGHT FOOT AND ANKLE).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    747401 HYPROCURE HYPROCURE SUBTALAR IMPLANT HWC GRAHAM MEDICAL TECHNOLOGIES, LLC. DBA GRAMEDICA HYP-07 071229141 M621HYP070

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Other