BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNKNOWN CURVED CUP IMPACTOR

    MDR report key: 2220606 · Received July 15, 2011

    Report

    Report Number
    2249697-2011-01066
    Event Type
    Malfunction
    Date Received
    July 15, 2011
    Date of Event
    June 24, 2011
    Report Date
    June 24, 2011
    Manufacturer
    STRYKER ORTHOPAEDICS MAHWAH
    Product Code
    HWA
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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, "UPON STRIKING THE PLATE, THE HANDLE OF THE IMPACTOR BROKEN RESULTING IN THE MOST SUPERIOR ASPECT BECOMING DISENGAGED."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNKNOWN CURVED CUP IMPACTOR INSTRUMENT HWA STRYKER ORTHOPAEDICS MAHWAH NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Other