BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CONSERVE(R) TOTAL A-CLASS HEAD

    MDR report key: 2060293 · Received April 15, 2011

    Report

    Report Number
    1043534-2011-00160
    Event Type
    Injury
    Date Received
    April 15, 2011
    Date of Event
    March 17, 2011
    Report Date
    March 17, 2011
    Manufacturer
    WRIGHT MEDICAL TECHNOLOGY, INC.
    Product Code
    JDL
    PMA / PMN Number
    K051348
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCLUSION: NO CONCLUSION CAN BE DRAWN. VISUALLY EXAMINED. COMPLAINT REVIEWED AND ANALYSIS SHOWED NO TREND FOR (B)(4) LOT NO: 126390071. DEVICE HISTORY RECORD REVIEWED.

    Additional Manufacturer Narrative · 1

    DEVICE #2: INVESTIGATION IS NOT COMPLETE. TRENDS WILL BE EVALUATED. NO COMPLAINT WAS STATED AGAINST THIS COMPONENT. THIS REPORT WILL BE UPDATED WHEN THE INVESTIGATION IS COMPLETE. THIS IS THE SAME EVENT AS 1043534-2011-00159, 00161.

    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) TOTAL A-CLASS HEAD HIP COMPONENT JDL WRIGHT MEDICAL TECHNOLOGY, INC. 086364258

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Hospitalization| R