BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN ZIMMER METASUL LINER

    MDR report key: 5999247 · Received October 5, 2016

    Report

    Report Number
    0001822565-2016-03515
    Event Type
    Injury
    Date Received
    October 5, 2016
    Report Date
    September 8, 2016
    Manufacturer
    ZIMMER, INC.
    Product Code
    KWZ
    PMA / PMN Number
    PN/A
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICES WERE NOT RETURNED AND NO PHOTOS WERE RECEIVED; THEREFORE, CONDITION OF THE DEVICES ARE UNKNOWN. THE LOT NUMBERS OF THE PRODUCTS ARE UNKNOWN; THEREFORE, THE DEVICE HISTORY RECORDS AND COMPLAINT HISTORY COULD NOT BE REVIEWED. COMPATIBILITY COULD NOT BE CONFIRMED AS PART NUMBERS ARE UNKNOWN. X-RAYS RECEIVED CONFIRMED THE DISLOCATION. THE REPORTED DEVICE IS USED FOR TREATMENT. A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED WITH THE INFORMATION PROVIDED.

    Additional Manufacturer Narrative · 1

    THIS REPORT WILL BE AMENDED WHEN OUR INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    IT IS REPORTED THAT UPON RECEIVING X-RAYS, IT WAS NOTED THAT THE PATIENT'S HIP ARTHROPLASTY HAD DISLOCATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    653391 UNKNOWN ZIMMER METASUL LINER HIP PROSTHESIS KWZ ZIMMER, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Other