BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HYPROCURE SINUS TARSI IMPLANT

    MDR report key: 14220273 · Received April 27, 2022

    Report

    Report Number
    3004993707-2022-00003
    Event Type
    Injury
    Date Received
    April 27, 2022
    Date of Event
    April 13, 2022
    Report Date
    April 25, 2022
    Manufacturer
    GRAHAM MEDICAL TECHNOLOGIES, LLC DBA GRAMEDICA
    Product Code
    HWC
    PMA / PMN Number
    K042030
    Removal / Correction Number
    MW5108220
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION OF DEVICE MANUFACTURING HISTORY RECORDS (AS WELL AS THE DEVICE PACKAGING AND STERILIZATION DOCUMENTATION) DID NOT REVEAL ANY NONCONFORMITIES. THE FACILITY / PHYSICIAN ACCEPTING THE DEVICE IS AN ADMISSION THAT THE HYPROCURE SINUS TARSI IMPLANT WAS RECEIVED WITH NO EVIDENCE OF PACKAGING OR DEVICE DAMAGE. WE BELIEVE THE DEVICE WAS MANUFACTURED, PACKAGED, AND DELIVERED IN GOOD ORDER. POST OPERATIVE PAIN IS A KNOWN POTENTIAL RISK AND IS NOT UNCOMMON FOR PATIENTS TO EXPERIENCE. EVERY PATIENT HAS UNIQUE MEDICAL CONSIDERATIONS AND THE ROOT CAUSE FOR PAIN CAN VARY FOR EACH PATIENT WHILE THEIR FOOT IS ADAPTING TO THE CORRECTED POSITION. THE HYPROCURE SINUS TARSI IMPLANT WHEN USED AS INTENDED, CAN BE REMOVED FROM THE SINUS TARSI, RETURNING THE ANKLE AND HEEL BONES BACK TO ITS PRE-SURGICAL STATE (THE IMPLANT DOES NOT ALTER THE BONES IN ANY WAY, IT IS PUSHED INTO PLACE WITH NO DRILLING OR SCREWING). WE CAN CONFIRM THAT A HYPROCURE IMPLANT, LOT # 060212181, AND SERIAL # (B)(4), WAS IMPLANTED BY DR. (B)(6) ON (B)(6) 2019.

    Description of Event or Problem · 0

    MANUFACTURER RECEIVED A NOTICE LETTER FROM FDA ON (B)(6) 2022. THIS LETTER WAS NOTIFYING THE MANUFACTURER OF A MEDWATCH REPORT MADE ON ONE OF THEIR MEDICAL DEVICES BY A PATIENT. ATTACHED WAS MDR REPORT (B)(4). THE EVENT WAS EXPLAINED AS HAVING PAIN. THE PATIENT STATED: "I HAVE A HYPROCURE STENT PLACED IN MY LEFT FOOT (B) (6) 2019. IT SEEMED TO BE FINE FOR 1 ½ YEARS, BUT NOW I CAN ONLY COMPARE THE PAIN TO A TENS UNIT TURNED UP TO HIGH. I ALSO MEASURED A SIGNAL FROM THE DEVICE WITH AN ELECTROMAGNETIC FREQUENCY METER. I DO BELIEVE THE DEVICE HAS COMMUNICATION CAPABILITIES. I DO NOT HAVE A LOT NUMBER OR CARD THAT SHOWS THE STENT PLACED ON MY FOOT WAS GENUINE. THE DEVICE IS STILL IN MY FOOT AND I AM SCHEDULED TO HAVE IT REMOVED IN ABOUT 2 WEEKS. PLEASE INVESTIGATE. FDA SAFETY REPORT ID # (B) (4)."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1840699 HYPROCURE SINUS TARSI IMPLANT SUBTALAR IMPLANT HWC GRAHAM MEDICAL TECHNOLOGIES, LLC DBA GRAMEDICA HYP-06 060212181

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR Female Other