BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GLADIATOR(R) BIPOLAR

    MDR report key: 2193396 · Received August 5, 2011

    Report

    Report Number
    1043534-2011-00396
    Event Type
    Injury
    Date Received
    August 5, 2011
    Report Date
    July 28, 2011
    Manufacturer
    WRIGHT MEDICAL TECHNOLOGY, INC.
    Product Code
    KWY
    PMA / PMN Number
    K062693
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCLUSION: NO CONCLUSION CAN BE DRAWN. THE COMPLAINT WAS REVIEWED. THE DEVICE HISTORY RECORD REVIEW INDICATES THAT ALL COMPONENTS OF THE GLADIATOR SHELL WERE IN SPECIFICATION WHEN MANUFACTURED. THE PRODUCT WAS NOT RETURNED. EVIDENCE THAT PRODUCT IN SPECIFICATION WHEN USED. UNDETERMINED.

    Additional Manufacturer Narrative · 1

    INVESTIGATION IS NOT COMPLETE. TRENDS WILL BE EVALUATED. ADDITIONAL INFORMATION HAS BEEN REQUESTED. THIS REPORT WILL BE UPDATED WHEN THE INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    ALLEGEDLY REVISED DUE TO DISASSOCIATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GLADIATOR(R) BIPOLAR HIP COMPONENT KWY WRIGHT MEDICAL TECHNOLOGY, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R