BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN ZIMMER HIP

    MDR report key: 6104407 · Received November 15, 2016

    Report

    Report Number
    0001822565-2016-04232
    Event Type
    Injury
    Date Received
    November 15, 2016
    Report Date
    April 6, 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
    TN, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    PART AND LOT NUMBER ARE REQUIRED TO REVIEW DEVICE HISTORY RECORDS AND NEITHER WERE PROVIDED. PRODUCT WAS NOT RETURNED SO NO PRODUCT EVALUATION COULD BE CONDUCTED. THIS DEVICE IS USED FOR TREATMENT. UNABLE TO PERFORM A COMPATIBILITY CHECK BASED ON PROVIDED INFORMATION. GENERIC COMPLAINT HISTORY FOR UNKNOWN PARTS IDENTIFIED NO TRENDS. 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 IS BEING CONSIDERED FOR A REVISION SURGERY, HOWEVER THE REASON FOR THE REVISION IS UNKNOWN AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    755545 UNKNOWN ZIMMER HIP HIP PROSTHESIS KWZ ZIMMER, INC. N/A NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Other