BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CONSERVE(R) PLUS HA CUP

    MDR report key: 3463781 · Received November 12, 2013

    Report

    Report Number
    1043534-2013-01871
    Event Type
    Injury
    Date Received
    November 12, 2013
    Date of Event
    June 3, 2009
    Report Date
    October 18, 2013
    Manufacturer
    WRIGHT MEDICAL TECHNOLOGY, INC.
    Product Code
    KWA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    COMPLAINT REVIEW WAS CONDUCTED AND ANAYLSIS SHOWED NO TREND FOR ITEM/LOT.

    Additional Manufacturer Narrative · 1

    INVESTIGATION IS NOT COMPLETE. TRENDS WILL BE EVALUATED. THIS REPORT WILL BE UPDATED WHEN THE INVESTIGATION IS COMPLETE. THIS EVENT OCCURRED IN (B)(6). THIS IS THE SAME EVENT AS 1043534-2013-001872.

    Description of Event or Problem · 1

    ALLEGEDLY REVISED DUE TO PAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    583434 CONSERVE(R) PLUS HA CUP HIP COMPONENT, CODE:KWA KWA WRIGHT MEDICAL TECHNOLOGY, INC. 114109645

    Patients

    Seq Age Sex Outcome Treatment
    1 60.9 YR Required Intervention