BEUDAMED
    FDA Adverse Event Injury Summary report: N

    32MM STANDARD FEMORAL HEAD

    MDR report key: 1915726 · Received November 29, 2010

    Report

    Report Number
    2249697-2010-01626
    Event Type
    Injury
    Date Received
    November 29, 2010
    Date of Event
    November 1, 2010
    Report Date
    November 3, 2010
    Manufacturer
    STRYKER ORTHOPAEDICS MAHWAH
    Product Code
    JDI
    PMA / PMN Number
    K831373
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AN EVALUATION OF THE DEVICE CANNOT BE PERFORMED AS THE DEVICE WAS NOT RETURNED TO THE MANUFACTURER. ADDITIONAL INFORMATION (INCLUDING X-RAYS AND MEDICAL RECORDS) WAS REQUESTED. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THE EVALUATION SUMMARY WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT, "THE POLYETHYLENE WAS WORN OUT. THE METAL WAS WEARING ON THE SHELL."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 32MM STANDARD FEMORAL HEAD IMPLANT JDI STRYKER ORTHOPAEDICS MAHWAH NA JNNTC

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Other| R