BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FEMORAL STEM INSERTER/EXTRACT

    MDR report key: 1874448 · Received October 12, 2010

    Report

    Report Number
    2249697-2010-01332
    Event Type
    Malfunction
    Date Received
    October 12, 2010
    Date of Event
    September 14, 2010
    Report Date
    September 16, 2010
    Manufacturer
    STREYKR ORTHOPAEDCIS MAHWAH
    Product Code
    LXH
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, 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: "DR WAS INSERTING THE RESTORATION PS FEMORAL STEM AND AS HE WAS IMPACTING THE INSERTER, THE ATTACHMENT OF THE STEM INSERTER BROKE OFF."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FEMORAL STEM INSERTER/EXTRACT INSTRUMENT LXH STREYKR ORTHOPAEDCIS MAHWAH NA TAXK409

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention