BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN ZIMMER SHELL

    MDR report key: 6079021 · Received November 4, 2016

    Report

    Report Number
    0001822565-2016-04085
    Event Type
    Injury
    Date Received
    November 4, 2016
    Date of Event
    October 6, 2016
    Report Date
    April 4, 2017
    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
    FL, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT WILL BE AMENDED WHEN OUR INVESTIGATION IS COMPLETE.

    Additional Manufacturer Narrative · 1

    PRODUCT WAS NOT RETURNED SO NO PRODUCT EVALUATION COULD BE CONDUCTED. PART AND LOT NUMBERS ARE REQUIRED TO REVIEW DEVICE HISTORY RECORDS AND NEITHER WERE PROVIDED. THIS DEVICE WAS USED FOR TREATMENT. UNABLE TO PERFORM A COMPATIBILITY CHECK BASED ON PROVIDED INFORMATION. GENERIC COMPLAINT HISTORY REVIEW WAS PERFORMED AS PART/LOT NUMBERS WERE NOT PROVIDED. RISK ASSESSMENT COULD NOT BE DONE DUE TO INSUFFICIENT INFORMATION. NO MEDICAL RECORDS WERE RECEIVED. ROOT CAUSE COULD NOT BE DETERMINED WITH INFORMATION AVAILABLE. NO CORRECTIVE ACTIONS, PREVENTIVE ACTIONS, OR FIELD ACTIONS RESULTED AFTER INVESTIGATION OF THIS EVENT.

    Description of Event or Problem · 1

    IT IS REPORTED THAT THE PATIENT'S HIP ARTHROPLASTY WAS REVISED DUE TO OSTEOLYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    731572 UNKNOWN ZIMMER SHELL HIP PROSTHESIS KWZ ZIMMER, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R