BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROFEMUR(R) RAZ STEM

    MDR report key: 1712811 · Received June 8, 2010

    Report

    Report Number
    1043534-2010-00134
    Event Type
    Injury
    Date Received
    June 8, 2010
    Date of Event
    April 26, 2010
    Report Date
    September 10, 2010
    Manufacturer
    WRIGHT MEDICAL TECHNOLOGY, INC.
    Product Code
    LPH
    PMA / PMN Number
    K021346
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION IS NOT COMPLETE. TRENDS WILL BE EVALUATED. THE EVENT DEVICE CODE IS ADDRESSED IN THE PACKAGE INSERT. ALTHOUGH SEVERAL ATTEMPTS HAVE BEEN MADE, A MEDWATCH 3500A WAS NOT RECEIVED FROM THE USER FACILITY. THIS REPORT WILL BE UPDATED WHEN THE INVESTIGATION IS COMPLETE. THIS IS THE SAME EVENT AS 1043534-2010-00133, 00135, 00136. PLEASE BE ADVISED: IN ERROR, THIS REPORT WAS SENT TO THE ESG TEST ACCOUNT RATHER THAN THE ESG PRODUCTION ACCOUNT. IT WAS FILED AT 03:26:02 PM ON MAY 17, 2010. I AM SENDING THIS TO THE PRODUCTION ACCOUNT TO CORRECT THIS ERROR.

    Additional Manufacturer Narrative · 1

    CONCLUSION: PRODUCT DID NOT CONTRIBUTE TO EVENT. 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 THE PATIENT HAD LATE INFECTION CAUSING LOOSENING OF THE ACETABULUM. POSSIBLE METAL REACTION.

    Description of Event or Problem · 1

    ALLEGEDLY THE PATIENT HAD LATE INFECTION CAUSING LOOSENING OF THE ACETABULUM. POSSIBLE METAL REACTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROFEMUR(R) RAZ STEM HIP COMPONENT LPH WRIGHT MEDICAL TECHNOLOGY, INC. 016284367

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R