BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN EON STEM

    MDR report key: 5233618 · Received November 18, 2015

    Report

    Report Number
    0002249697-2015-03879
    Event Type
    Injury
    Date Received
    November 18, 2015
    Date of Event
    October 29, 2015
    Report Date
    October 29, 2015
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    JDG
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AN EVALUATION OF THE DEVICE CANNOT BE PERFORMED AS THE DEVICE WAS NOT RETURNED TO THE MANUFACTURER. ADDITIONAL INFORMATION WAS REQUESTED AND IF IT BECOMES AVAILABLE WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT'S HIP WAS REVISED DUE TO A LOOSE STEM. SURGEON REVISED BIPOLAR, EON STEM AND +10 METAL HEAD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    762237 UNKNOWN EON STEM HIP IMPLANT JDG STRYKER ORTHOPAEDICS-MAHWAH UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention