BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HYPROCURE

    MDR report key: 11852012 · Received May 19, 2021

    Report

    Report Number
    3004993707-2021-00008
    Event Type
    Injury
    Date Received
    May 19, 2021
    Date of Event
    July 26, 2019
    Report Date
    April 12, 2021
    Manufacturer
    GRAHAM MEDICAL TECHNOLOGIES, LLC. DBA GRAMEDICA
    Product Code
    HWC
    UDI-DI
    M621HYP050
    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 DEVICE INSTRUCTIONS FOR USE INCLUDES PAIN AND DISCOMFORT AS POTENTIAL ADVERSE EFFECTS.

    Description of Event or Problem · 1

    I HAVE LASTING PAIN IF I SIT/SLEEP WITH MY ANKLE IN A TURNED INWARD POSITION. THE PAIN IS ABOVE THE INCISION AND ABOUT THE SIZE OF A QUARTER. WHEN I TRIED TO WEAR HIGH HEELS, I HAD MODERATE PAIN AND MY ANKLES FELT VERY UNSTABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    746406 HYPROCURE HYPROCURE SUBTALAR IMPLANT HWC GRAHAM MEDICAL TECHNOLOGIES, LLC. DBA GRAMEDICA HYP-05 050212181 M621HYP050

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR Other