BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROFEMUR(R) Z STEM PLASMA SPRAYED

    MDR report key: 2832487 · Received November 14, 2012

    Report

    Report Number
    1043534-2012-01557
    Event Type
    Injury
    Date Received
    November 14, 2012
    Date of Event
    October 12, 2010
    Report Date
    October 16, 2012
    Manufacturer
    WRIGHT MEDICAL TECHNOLOGY, INC.
    Product Code
    LPH
    PMA / PMN Number
    K021346
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION IS NOT COMPLETE. TRENDS WILL BE EVALUATED. THIS REPORT WILL BE UPDATED WHEN THE INVESTIGATION IS COMPLETE. THIS IS THE SAME EVENT AS 1043534-2012-00056, 01556, 01558.

    Additional Manufacturer Narrative · 1

    CONCLUSION: NO DEVICE FAILURE.THE COMPLAINT WAS REVIEWED AND ANALYSIS SHOWED NO TREND FOR ITEM/LOT. THE PRODUCT WAS NOT RETURNED.EVIDENCE THAT PRODUCT IN SPECIFICATION WHEN USEDUNDETERMINED.

    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) Z STEM PLASMA SPRAYED HIP COMPONENT, CODE:LPH LPH WRIGHT MEDICAL TECHNOLOGY, INC. 107475451

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention