BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CONSERVE(R) TOTAL HEAD W/BFH

    MDR report key: 1843125 · Received September 23, 2010

    Report

    Report Number
    1043534-2010-00393
    Event Type
    Injury
    Date Received
    September 23, 2010
    Date of Event
    September 14, 2009
    Report Date
    July 8, 2011
    Manufacturer
    WRIGHT MEDICAL TECHNOLOGY, INC.
    Product Code
    KWA
    PMA / PMN Number
    K021349
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION IS NOT COMPLETE. TRENDS WILL BE EVALUATED. NO COMPLAINT WAS STATED AGAINST THIS DEVICE. ALTHOUGH SEVERAL ATTEMPTS HAVE BEEN MADE, NO USER FACILITY HAS BEEN IDENTIFY TO DATE. THIS REPORT WILL BE UPDATED WHEN THE INVESTIGATION IS COMPLETE. THIS IS THE SAME EVENT AS 1043534-2010-00392, 00394, 00395.

    Additional Manufacturer Narrative · 1

    CONCLUSION: PRODUCT DID NOT CONTRIBUTE TO EVENT. PRODUCT NOT RETURNED. COMPLAINT HISTORY REVIEWED. DEVICE HISTORY RECORD REVIEWED.EVIDENCE THAT PRODUCT IN SPEC WHEN USED. USE OF DEVICE COULD NOT BE DETERMINED.

    Description of Event or Problem · 1

    ALLEGEDLY REVISED DURING THE REMOVAL OF ANOTHER COMPONENT.

    Description of Event or Problem · 1

    ALLEGEDLY REVISED DURING THE REMOVAL OF ANOTHER COMPONENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CONSERVE(R) TOTAL HEAD W/BFH HIP COMPONENT KWA WRIGHT MEDICAL TECHNOLOGY, INC. 016302010

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Hospitalization| R