BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROFEMUR(R) Z STEM PLASMA SPRAYED

    MDR report key: 2080734 · Received May 6, 2011

    Report

    Report Number
    1043534-2011-00197
    Event Type
    Injury
    Date Received
    May 6, 2011
    Date of Event
    March 30, 2011
    Report Date
    April 7, 2011
    Manufacturer
    WRIGHT MEDICAL TECHNOLOGY, INC.
    Product Code
    LPH
    PMA / PMN Number
    K021346
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN

    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 3500A HAS BEEN RECEIVED FROM THE USER FACILITY. THIS REPORT WILL BE UPDATED WHEN THE INVESTIGATION IS COMPLETE. THIS IS THE SAME EVENT AS 1043534-2011-00196, 00198.

    Additional Manufacturer Narrative · 1

    CONCLUSION: NO DEVICE FAILURE. VISUALLY EXAMINED. COMPLAINT REVIEWED AND ANALYSIS SHOWED NO TREND FOR (B)(4) LOT NO: 127506370. DEVICE HISTORY RECORD REVIEWED. (B)(4).

    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 LPH WRIGHT MEDICAL TECHNOLOGY, INC. 127506370

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Hospitalization| R