BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN_CORK_PRODUCT

    MDR report key: 3781275 · Received April 30, 2014

    Report

    Report Number
    0002249697-2014-01610
    Event Type
    Injury
    Date Received
    April 30, 2014
    Date of Event
    April 8, 2014
    Report Date
    April 8, 2014
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    JDI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CATALOG NUMBER IS UNKNOWN AT THIS TIME. THE DEVICE WAS REPORTED AS AN UNKNOWN MDM POLY INSERT. ADDITIONAL DEVICES REPORTED WERE: UNKNOWN MDM LINER; UNKNOWN 28MM V-40 HEAD; UNKNOWN CHOKE GRIP. IT CANNOT BE DETERMINED WHICH, IF ANY OF THESE DEVICES MAY HAVE CAUSED OR CONTRIBUTED TO THE PATIENT'S EXPERIENCE. IT WAS NOTED THAT THE DEVICES ARE NOT AVAILABLE FOR EVALUATION DUE TO HOSPITAL POLICY. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IF RECEIVED, WILL BE PROVIDED IN THE SUPPLEMENTAL REPORT UPON COMPLETION OF THE INVESTIGATION. NOT RETURNED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS A LEFT HIP REVISED, WASHOUT AND (B)(6) DUE TO INFECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    258773 UNKNOWN_CORK_PRODUCT IMPLANT JDI STRYKER ORTHOPAEDICS-MAHWAH UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Hospitalization| R