BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN ZIMMER HIP

    MDR report key: 6053917 · Received October 25, 2016

    Report

    Report Number
    0001822565-2016-03905
    Event Type
    Injury
    Date Received
    October 25, 2016
    Report Date
    September 29, 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
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT WILL BE AMENDED WHEN OUR INVESTIGATION IS COMPLETE.

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING FILED TO RELAY CORRECTED AND ADDITIONAL INFORMATION. CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A CONCLUSION AS TO THE CAUSE OF THE EVENT. NO DEVICES OR PHOTOS OF THE DEVICES WERE RECEIVED; THEREFORE, THE CONDITION OF THE COMPONENTS IS UNKNOWN. ADDITIONALLY, VISUAL AND DIMENSIONAL EVALUATIONS COULD NOT BE PERFORMED. THE PRODUCT NUMBER AND THE LOT NUMBER WERE NOT PROVIDED; THEREFORE, THE COMPLAINT HISTORY, MANUFACTURING DATE, THE DEVICE HISTORY RECORDS AND THE FIELD AGE OF THE DEVICE COULD NOT BE DETERMINED. INSUFFICIENT INFORMATION WAS PROVIDED TO PERFORM A COMPLAINT HISTORY SEARCH. THIS DEVICE IS USED FOR TREATMENT. INSUFFICIENT INFORMATION WAS PROVIDED TO PERFORM A COMPATIBILITY CHECK. SURGICAL NOTES WERE NOT PROVIDED. IT COULD NOT BE CONFIRMED IF THE DEVICES WERE USED IN AN APPROVED AND COMPATIBLE COMBINATION. IT IS UNKNOWN WHETHER THE COMPONENTS WERE IMPLANTED WITH THE CORRECT FIT AND ORIENTATION AS PER THE SURGICAL TECHNIQUE. RELEVANT MEDICAL HISTORY AND ADHERENCE TO REHABILITATION PROTOCOL ARE ALSO UNKNOWN. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED WITH THE INFORMATION PROVIDED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT IS NEEDING A REVISION OF A HIP ARTHROPLASTY DUE TO UNKNOWN REASONS.

    Description of Event or Problem · 1

    POT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    705823 UNKNOWN ZIMMER HIP HIP PROSTHESIS KWZ ZIMMER, INC. N/A NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Other