BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GLADIATOR(R) BIPOLAR

    MDR report key: 2830853 · Received November 13, 2012

    Report

    Report Number
    1043534-2012-01542
    Event Type
    Injury
    Date Received
    November 13, 2012
    Date of Event
    October 13, 2012
    Report Date
    October 16, 2012
    Manufacturer
    WRIGHT MEDICAL TECHNOLOGY, INC.
    Product Code
    KWY
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION IS NOT COMPLETE. TRENDS WILL BE EVALUATED. THE EVENT CODE IS ADDRESSED IN THE PACKAGE INSERT. THIS REPORT WILL BE UPDATED WHEN THE INVESTIGATION IS COMPLETE. THIS IS THE SAME EVENT AS 1043534-2012-01543, 01544

    Additional Manufacturer Narrative · 1

    CONCLUSION: NO CONCLUSION CAN BE DRAWN. THE COMPLAINT WAS REVIEWED AND ANALYSIS SHOWED NO TREND FOR ITEM/LOT. THE PACKAGE INSERT WAS ALSO REVIEWED. THE PRODUCT WAS NOT RETURNED. (B)(4): EVIDENCE THAT PRODUCT IN SPECIFICATION WHEN USED.

    Description of Event or Problem · 1

    ALLEGEDLY PATIENT HAD A BIPOLAR HIP REPLACEMENT AND DISLOCATED POST-OP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GLADIATOR(R) BIPOLAR HIP COMPONENT, CODE:KWY KWY WRIGHT MEDICAL TECHNOLOGY, INC. 0511345070

    Patients

    Seq Age Sex Outcome Treatment
    1 89 YR Required Intervention