BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CONSERVE(R) PLUS CUP

    MDR report key: 2874401 · Received December 14, 2012

    Report

    Report Number
    1043534-2012-01685
    Event Type
    Injury
    Date Received
    December 14, 2012
    Date of Event
    November 14, 2012
    Report Date
    November 14, 2012
    Manufacturer
    WRIGHT MEDICAL TECHNOLOGY, INC.
    Product Code
    KWA
    PMA / PMN Number
    K021349
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION IS NOT COMPLETE. TRENDS WILL BE EVALUATED. THIS REPORT WILL BE UPDATED WHEN THE INVESTIGATION IS COMPLETE. THIS IS THE SAME EVENT AS 1043534-2012-01683, 01684, 01686.

    Additional Manufacturer Narrative · 1

    CONCLUSION: NO DEVICE FAILURE. THE COMPLAINT WAS REVIEWED AND ANALYSIS SHOWED NO TREND FOR ITEM/LOT. THE PRODUCT WAS NOT RETURNED. (B)(4).

    Description of Event or Problem · 1

    ALLEGEDLY REMOVED DURING THE REVISION OF ANOTHER COMPONENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CONSERVE(R) PLUS CUP HIP COMPONENT, CODE:KWA KWA WRIGHT MEDICAL TECHNOLOGY, INC. 059842575

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Required Intervention