BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN_CORK_PRODUCT

    MDR report key: 3852228 · Received June 5, 2014

    Report

    Report Number
    0002249697-2014-02135
    Event Type
    Injury
    Date Received
    June 5, 2014
    Date of Event
    May 15, 2014
    Report Date
    May 15, 2014
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    JDI
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE CATALOG NUMBER AND LOT CODE WERE NOT PROVIDED. THE DEVICE WAS REPORTED AS AN UNKNOWN CERAMIC FEMORAL HEAD. IT WAS NOTED THAT THE DEVICE IS NOT AVAILABLE FOR EVALUATION BECAUSE IT WAS DISCARDED BY THE HOSPITAL. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IF RECEIVED, WILL BE PROVIDED IN THE SUPPLEMENTAL REPORT UPON COMPLETION OF THE INVESTIGATION. DISCARDED BY HOSPITAL.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS A LEFT HIP REVISED DUE TO CERAMIC HEAD BEING BROKEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    329023 UNKNOWN_CORK_PRODUCT IMPLANT JDI STRYKER ORTHOPAEDICS-MAHWAH UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Hospitalization| O| R