BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN_RECONSTRUCTIVE_PRODUCT

    MDR report key: 4161971 · Received October 10, 2014

    Report

    Report Number
    0002249697-2014-03826
    Event Type
    Injury
    Date Received
    October 10, 2014
    Date of Event
    November 17, 2010
    Report Date
    September 8, 2014
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    MEH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CATALOG NUMBER UNKNOWN AT THIS TIME. DEVICE DESCRIPTION REPORTED AS UNKNOWN REJUVENATE/ABGII MODULAR STEM. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IF RECEIVED WILL BE SUBMITTED IN A FOLLOW UP REPORT UPON COMPLETION OF THE INVESTIGATION. CURRENTLY IMPLANTED

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT HAS 6 INCH HAIRLINE FRACTURED FEMUR, PAIN, MEMORY LOSS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    643785 UNKNOWN_RECONSTRUCTIVE_PRODUCT IMPLANT MEH STRYKER ORTHOPAEDICS-MAHWAH UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other