BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROFEMUR(R) TL STEM

    MDR report key: 1843093 · Received September 23, 2010

    Report

    Report Number
    1043534-2010-00387
    Event Type
    Injury
    Date Received
    September 23, 2010
    Date of Event
    February 23, 2009
    Report Date
    September 24, 2010
    Manufacturer
    WRIGHT MEDICAL TECHNOLOGY, INC.
    Product Code
    KWA
    PMA / PMN Number
    K060358
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE #4:CORRECTED DATA/ADDITIONAL INFORMATION: RECEIVED 9/23/10 FROM THE USER FACILITY. THE RISK MGR. ADVISES OUR PRODUCT DID NOT CAUSE OR CONTRIBUTE TO THIS REVISION SURGERY; THEREFORE, THIS MEDWATCH 3500A WAS NOT REQUIRED. THIS IS THE SAME EVENT AS 1043534-2010-00384, 00385, 00386.

    Additional Manufacturer Narrative · 1

    DEVICE #4: INVESTIGATION IS NOT COMPLETE. TRENDS WILL BE EVALUATED. NO COMPLAINT WAS STATED AGAINST THIS COMPONENT. ALTHOUGH SEVERAL ATTEMPTS HAVE BEEN MADE, A MEDWATCH 3500A HAS NOT BEEN RECEIVED BY THE USER FACILITY. THIS REPORT WILL BE UPDATED WHEN THE INVESTIGATION IS COMPLETE. THIS IS THE SAME EVENT AS 1043534-2010-00384, 00385, 00386.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE CUSTOMER THAT ON (B)(6) 2010, THE AIMING BEAM FIRED STRAIGHT OUT OF THE FIBER AT 105,363 JOULES. NO INJURY WAS REPORTED. THE DEVICE WAS NOT RETURNED TO AMERICAN MEDICAL SYSTEMS FOR EVAL.

    Description of Event or Problem · 1

    ALLEGEDLY REVISED DURING THE REVISION OF ANOTHER COMPONENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROFEMUR(R) TL STEM HIP COMPONENT KWA WRIGHT MEDICAL TECHNOLOGY, INC. 018504531

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Hospitalization| R