BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROFEMUR(R) RAZ STEM

    MDR report key: 2515418 · Received April 3, 2012

    Report

    Report Number
    1043534-2012-00276
    Event Type
    Injury
    Date Received
    April 3, 2012
    Date of Event
    February 29, 2012
    Report Date
    March 1, 2012
    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. NO COMPLAINT WAS STATED AGAINST THIS DEVICE. ALTHOUGH SEVERAL ATTEMPTS HAVE BEEN MADE, NO MEDWATCH 3500 HAS BEEN RECEIVED FROM THE USER FACILITY. THIS REPORT WILL BE UPDATED WHEN THE INVESTIGATION IS COMPLETE. THIS IS THE SAME EVENT AS 1043534-2012-00273, 00274, 00275.

    Additional Manufacturer Narrative · 1

    CONCLUSION: NO CONCLUSION CAN BE DRAWN.COMPLAINT REVIEWED AND ANALYSIS SHOWED NO TREND FOR PYRD-0006 LOT NO: 077426985. DEVICE HISTORY RECORD REVIEWED. PRODUCT NOT RETURNED.EVIDENCE THAT PRODUCT IN SPECIFICATION WHEN USED.

    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 PROFEMUR(R) RAZ STEM HIP COMPONENT LPH WRIGHT MEDICAL TECHNOLOGY, INC. 077426985

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Hospitalization| R