BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HYPROCURE II SINUS TARSI IMPLANT SYSTEM

    MDR report key: 14222002 · Received April 27, 2022

    Report

    Report Number
    3004993707-2022-00002
    Event Type
    Injury
    Date Received
    April 27, 2022
    Date of Event
    May 4, 2021
    Report Date
    April 1, 2022
    Manufacturer
    GRAHAM MEDICAL TECHNOLOGIES, LLC DBA GRAMEDICA
    Product Code
    HWC
    UDI-DI
    M621HYPII110
    PMA / PMN Number
    K142534
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    A MULTI-CENTER POST MARKET CLINICAL FOLLOW-UP (PMCF) 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 THIS PATIENT ISSUE PRIOR TO THE REPORT STUDY AND NO COMPLAINTS HAVE BEEN MADE. THE DEVICE INSTRUCTIONS FOR USE (IFU) INCLUDES WARNINGS - SPECIFICALLY, IT IS VERY IMPORTANT TO SELECT THE CORRECT SIZE OF THE IMPLANT TO ACHIEVE THE BEST POSSIBLE CORRECTION AND A VERY CRITICAL PART OF THE SURGERY IS COMPLETE CUTTING OF THE TALOCALCANEAL LIGAMENT DEEP IN THE CANALIS PORTION OF THE SINUS TARSI.

    Description of Event or Problem · 0

    THE PATIENT DESCRIBED BEING 'VERY SATISFIED' WITH THE DEVICE. AT 2 WEEKS POST-OP APPOINTMENT, THE IMPLANT HAD A SLIGHT LATERAL DEVIATION AND SURGICAL REVISION WAS SCHEDULED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    912600 HYPROCURE II SINUS TARSI IMPLANT SYSTEM SUBTALAR IMPLANT HWC GRAHAM MEDICAL TECHNOLOGIES, LLC DBA GRAMEDICA HYPII-11 110221171 M621HYPII110

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Female Other