BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SIGN HIP CONSTRUCT

    MDR report key: 6351326 · Received February 22, 2017

    Report

    Report Number
    3034525-2017-00017
    Event Type
    Injury
    Date Received
    February 22, 2017
    Date of Event
    February 14, 2017
    Report Date
    February 16, 2017
    Manufacturer
    SIGN FRACTURE CARE INTERNATIONAL
    Product Code
    HSB
    PMA / PMN Number
    K152727
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MG
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A PRODUCT INVESTIGATION WAS PERFORMED FOR THIS DEVICE. THE ACTUAL DEVICE WAS NOT RETURNED TO THE MANUFACTURER FOR EVALUATION. THE ROOT CAUSE OF THE FAILURE TO HEAL IS UNDETERMINED. THE RADIOGRAPHIC AND CLINICAL DATA WERE REVIEWED BY A SIGN ORTHOPEDIC SURGEON. A SECOND SURGERY WAS PERFORMED TO REMOVE THE SIGN HIP CONSTRUCT (SHC) AND PERFORM A TOTAL HIP REPLACEMENT. SIGN FRACTURE CARE INTERNATIONAL CONTINUES TO MONITOR THESE EVENTS AS PART OF OUR POST MARKET ACTIVITIES.

    Description of Event or Problem · 1

    WE BECAME AWARE ON (B)(6) 2017, THAT A SIGN HIP CONSTRUCT (SHC) IMPLANTED TO REPAIR A FRACTURE HAD TO BE REMOVED DUE TO FAILURE TO HEAL. THE PATIENT THEN RECEIVED A TOTAL HIP REPLACEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    134360 SIGN HIP CONSTRUCT INTRAMEDULLARY FIXATION ROD HSB SIGN FRACTURE CARE INTERNATIONAL

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Hospitalization| R