BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN PRODUCT - EXETER 35.5MM STEM

    MDR report key: 1890003 · Received November 1, 2010

    Report

    Report Number
    9616680-2010-00701
    Event Type
    Injury
    Date Received
    November 1, 2010
    Date of Event
    October 15, 2010
    Report Date
    October 15, 2010
    Manufacturer
    STRYKER ORTHOPAEDICS CORK
    Product Code
    KWY
    PMA / PMN Number
    UNK
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NZ
    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. STEM WAS DISCARDED. IF ADDITIONAL INFO BECOMES AVAILABLE, IT WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    AN EXETER 35.5MM DDH STEM THAT WAS IMPLANTED IN A PT HAD FRACTURED AND WAS TO BE REVISED. THE CEMENT MANTLE WAS INTACT AND THE INTERVENTION WAS TO IMPLANT A 33MM DDH STEM IN THE EXISTING MANTLE. AS THE STEM HAD FRACTURED THERE WAS A COMPLICATION WITH THE REMOVAL OF THE DISTAL PORTION OF THE STEM FROM THE CEMENT MANTLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNKNOWN PRODUCT - EXETER 35.5MM STEM IMPLANT KWY STRYKER ORTHOPAEDICS CORK NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention