BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN ZIMMER HIP

    MDR report key: 6109000 · Received November 17, 2016

    Report

    Report Number
    0001822565-2016-04255
    Event Type
    Injury
    Date Received
    November 17, 2016
    Report Date
    May 25, 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

    UPON REASSESSMENT OF THE REPORTED EVENT, IT WAS DETERMINED TO BE NOT REPORTABLE AS THIS COMPLAINT WAS FOR A REQUEST FOR PRODUCT IDENTIFICATION ONLY. THERE WAS NO ALLEGED DEFICIENCY RELATED TO THE IDENTITY, QUALITY, DURABILITY, RELIABILITY, SAFETY, EFFECTIVENESS OR PERFORMANCE OF THE PRODUCT. AS SUCH, THIS INFORMATION IS CONSIDERED AN INQUIRY AND THE COMPLAINT FILE IS BEING CLOSED AS NOT A COMPLAINT. IF ADDITIONAL INFORMATION IS RECEIVED THAT ALLEGES A PRODUCT DEFICIENCY, THE COMPLAINT WILL BE RE-OPENED AND EVALUATED AT THAT TIME.

    Description of Event or Problem · 1

    IT IS REPORTED THAT THE PATIENT'S HIP ARTHROPLASTY IS BEING CONSIDERED FOR A REVISION FOR AN UNKNOWN REASON.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    760526 UNKNOWN ZIMMER HIP HIP PROSTHESIS KWZ ZIMMER, INC. N/A NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Other