BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HYPROCURE

    MDR report key: 11852030 · Received May 19, 2021

    Report

    Report Number
    3004993707-2021-00020
    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
    M621HYP060
    PMA / PMN Number
    K042030
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    003

    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 A WARNING - IT IS VERY IMPORTANT TO SELECT THE CORRECT SIZE OF THE IMPLANT TO ACHIEVE THE BEST POSSIBLE CORRECTION.

    Description of Event or Problem · 1

    DEVICE MIGRATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    747070 HYPROCURE HYPROCURE SUBTALAR IMPLANT HWC GRAHAM MEDICAL TECHNOLOGIES, LLC. DBA GRAMEDICA HYP-06 061219132 M621HYP060

    Patients

    Seq Age Sex Outcome Treatment
    1 10 YR Other