BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN_RECONSTRUCTIVE_PRODUCT

    MDR report key: 3910700 · Received July 2, 2014

    Report

    Report Number
    0002249697-2014-02523
    Event Type
    Injury
    Date Received
    July 2, 2014
    Date of Event
    June 5, 2014
    Report Date
    June 5, 2014
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    MEH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE CATALOG NUMBER AND LOT CODE WERE NOT PROVIDED. THE DEVICE WAS REPORTED AS AN UNKNOWN POLY. ADDITIONALLY, AN UNKNOWN METAL LINER AND UNKNOWN HEAD WERE ALSO REPORTED. IT CANNOT BE DETERMINED WHICH, IF ANY OF THESE DEVICES MAY HAVE CAUSED OR CONTRIBUTED TO THE PATIENT'S EXPERIENCE. THE SALES REP NOTED THAT NO ADDITIONAL INFORMATION WOULD BE PROVIDED BY THE HOSPITAL. HOSPITAL RETAINED DEVICE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT'S LEFT HIP WAS BEING REVISED DUE TO INFECTION. THE SURGEON PERFORMED AN I & D AND SWAPPED THE POLY, METAL LINER AND HEAD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    386399 UNKNOWN_RECONSTRUCTIVE_PRODUCT IMPLANT MEH STRYKER ORTHOPAEDICS-MAHWAH UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Hospitalization| R