BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CUSTOM OFFSET ACCOLADE QUICK

    MDR report key: 2133719 · Received June 9, 2011

    Report

    Report Number
    2249697-2011-00854
    Event Type
    Injury
    Date Received
    June 9, 2011
    Date of Event
    May 24, 2011
    Report Date
    May 24, 2011
    Manufacturer
    STRYKER ORTHOPAEDICS MAHWAH
    Product Code
    MEH
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AN EVAL OF THE DEVICE CANNOT BE PERFORMED AS THE DEVICE WAS NOT RETURNED TO THE MFR AT THIS TIME. IF ADD'L INFO BECOMES AVAILABLE THEN IT WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT, "THE DOCTOR WAS IMPACTING WITH THE CURVED STEM IMPACTOR. WHILE IMPACTING THE HIP STEM, IT MOVED TO WHERE IT FRACTURED THE GREATER TROCHANTER."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CUSTOM OFFSET ACCOLADE QUICK INSTRUMENT MEH STRYKER ORTHOPAEDICS MAHWAH NA NE3KK1

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention