BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EXETER STEM

    MDR report key: 1033838 · Received April 24, 2008

    Report

    Report Number
    9610669-2008-00008
    Event Type
    Injury
    Date Received
    April 24, 2008
    Date of Event
    April 1, 2008
    Report Date
    April 1, 2008
    Manufacturer
    STRYKER ORTHOPAEDICS CAEN
    Product Code
    KWY
    PMA / PMN Number
    UNK
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    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. IF ADD'L INFO BECOMES AVAILABLE, IT WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE EXETER STEM HAD FRACTURED AND THE PT WAS REVISED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EXETER STEM IMPLANT KWY STRYKER ORTHOPAEDICS CAEN UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention