BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DURACON MODULAR NON-BEADED CR FEMUR ASY

    MDR report key: 1871262 · Received October 13, 2010

    Report

    Report Number
    2249697-2010-01353
    Event Type
    Injury
    Date Received
    October 13, 2010
    Date of Event
    September 21, 2010
    Report Date
    September 21, 2010
    Manufacturer
    STRYKER ORTHOPAEDICS MAHWAH
    Product Code
    JWH
    PMA / PMN Number
    K910235
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, 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. ADD'L INFO (INCLUDING X-RAYS AND MEDICAL RECORDS) WAS REQUESTED, BUT NOT MADE AVAILABLE. IF DEVICE OR ADD'L INFO BECOMES AVAILABLE, THE EVAL SUMMARY WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT: "COMPONENTS LOOSENED." ADD'L INFO: IT WAS CONFIRMED WITH THE SALES REP THAT THE FEMORAL COMPONENT ASSEMBLY WAS LOOSENED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DURACON MODULAR NON-BEADED CR FEMUR ASY IMPLANT JWH STRYKER ORTHOPAEDICS MAHWAH NA CXDOD

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention