BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN_RECONSTRUCTIVE_PRODUCT

    MDR report key: 3870626 · Received June 12, 2014

    Report

    Report Number
    0002249697-2014-02242
    Event Type
    Injury
    Date Received
    June 12, 2014
    Date of Event
    November 7, 2011
    Report Date
    May 21, 2014
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    JDI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE CATALOG NUMBER AND LOT CODE OF THE FEMORAL COMPONENT WERE NOT PROVIDED. AN UNKNOWN STEM WAS ADDED BASED UPON THE DETAILS OF THE EVENT DESCRIPTION. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND THE CONTACT INDICATED THAT NO FURTHER INFORMATION WOULD BE AVAILABLE FOR EVALUATION OF THE REPORTED EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS A RIGHT TOTAL HIP ARTHROPLASTY REVISION DUE TO FEMORAL COMPONENT LOOSENING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    348245 UNKNOWN_RECONSTRUCTIVE_PRODUCT IMPLANT JDI STRYKER ORTHOPAEDICS-MAHWAH UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Hospitalization| R