BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN ZIMMER HIP

    MDR report key: 6106774 · Received November 16, 2016

    Report

    Report Number
    0001822565-2016-04251
    Event Type
    Injury
    Date Received
    November 16, 2016
    Date of Event
    January 1, 2015
    Report Date
    November 16, 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
    TH
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    INFORMATION WAS RECEIVED VIA THE ATTACHED JOURNAL ARTICLE. KIATISEVI ET AL. "FUNCTIONAL OUTCOME AND COMPLICATIONS FOLLOWING RECONSTRUCTION FOR HARRINGTON CLASS II AND III PERIACETABULAR METASTASIS" WORLD JOURNAL OF SURGICAL ONCOLOGY 2015, 13:4.

    Additional Manufacturer Narrative · 1

    NO DEVICE OR PHOTO WAS PROVIDED THEREFORE THE CONDITION OF THE COMPONENT IS UNKNOWN. DEVICE HISTORY RECORDS CANNOT BE REVIEWED SINCE THE PART AND LOT NUMBERS ARE UNKNOWN. THE REPORTED DEVICE IS USED FOR THE TREATMENT. COMPLAINT HISTORY SEARCH CANNOT BE REVIEWED SINCE THE PART AND LOT NUMBERS ARE UNKNOWN. COMPATIBILITY CANNOT BE CHECKED DUE TO INSUFFICIENT INFORMATION. MEDICAL RECORDS WERE NOT PROVIDED. RELEVANT MEDICAL HISTORY AND ADHERENCE TO REHABILITATION PROTOCOL ARE UNKNOWN. A DEFINITE ROOT CAUSE CANNOT BE DETERMINED WITH THE INFORMATION PROVIDED.

    Description of Event or Problem · 1

    IT WAS REPORTED IN A JOURNAL ARTICLE THAT TWO PATIENTS EXPERIENCED DEEP VEIN THROMBOSIS AN UNKNOWN DATE. NO FURTHER INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    758741 UNKNOWN ZIMMER HIP HIP PROSTHESIS KWZ ZIMMER, INC. N/A NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Other