BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CONSERVE(R) TOTAL A-CLASS

    MDR report key: 2020514 · Received March 16, 2011

    Report

    Report Number
    1043534-2011-00087
    Event Type
    Injury
    Date Received
    March 16, 2011
    Date of Event
    November 1, 2010
    Report Date
    February 14, 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
    CA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCLUSION: NO CONCLUSION CAN BE DRAWN. EVIDENCE THAT PRODUCT WAS IN SPEC WHEN USED.

    Additional Manufacturer Narrative · 1

    DEVICE #4:INVESTIGATION IS NOT COMPLETE. TRENDS WILL BE EVALUATED. NO COMPLAINT WAS STATED AGAINST THIS DEVICE. THIS REPORT WILL BE UPDATED WHEN THE INVESTIGATION IS COMPLETE. THIS IS THE SAME EVENT AS 1043534-2011-00018, 00017, 00086.

    Description of Event or Problem · 1

    ALLEGEDLY THE COMPONENT WAS REMOVED DURING THE REVISION OF ANOTHER COMPONENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CONSERVE(R) TOTAL A-CLASS HIP COMPONENT JDL WRIGHT MEDICAL TECHNOLOGY, INC. 067445890

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R