BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UHR BIPOLAR 28X48MM

    MDR report key: 2062585 · Received April 8, 2011

    Report

    Report Number
    2249697-2011-00433
    Event Type
    Injury
    Date Received
    April 8, 2011
    Date of Event
    March 15, 2011
    Report Date
    March 15, 2011
    Manufacturer
    STRYKER ORTHOPAEDICS MAHWAH
    Product Code
    KWL
    PMA / PMN Number
    K800207
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT, "PATIENT WAS DISLOCATING. THE BIPOLAR COMPONENT AND FEMORAL HEAD CAME APART, SO REVISION WAS REQUIRED."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UHR BIPOLAR 28X48MM IMPLANT KWL STRYKER ORTHOPAEDICS MAHWAH NA MJKX78

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other| R