BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROFEMUR(R) Z STEM PLASMA SPRAYED

    MDR report key: 3122284 · Received May 21, 2013

    Report

    Report Number
    1043534-2013-00822
    Event Type
    Injury
    Date Received
    May 21, 2013
    Date of Event
    April 16, 2012
    Report Date
    April 19, 2013
    Manufacturer
    WRIGHT MEDICAL TECHNOLOGY, INC.
    Product Code
    LPH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION HAS BEEN REOPENED. THIS REPORT WILL BE UPDATED WHEN THE INVESTIGATION IS COMPLETE. TRENDS WILL BE EVALUATED. THE EVENT CODE IS ADDRESSED IN THE PACKAGE INSERT. THIS IS THE SAME EVENT AS 1043534-2013-00820, 00821, 00823.

    Additional Manufacturer Narrative · 1

    CONCLUSION: NO CONCLUSION CAN BE DRAWN. THE COMPLAINT WAS REVIEWED AND ANALYSIS SHOWED NO TREND FOR ITEM/LOT. THE PACKAGE INSERT WAS ALSO REVIEWED. THE PRODUCT WAS NOT RETURNED. EVIDENCE THAT PRODUCT IN SPECIFICATION WHEN USED.

    Description of Event or Problem · 1

    ALLEGEDLY ON (B)(6) 2006 INTERNAL AND EXTERNAL ROTATION OF THE RIGHT HIP CAUSES CLICKING IN RIGHT HIP WITH PAIN. ON (B)(6) 2007 PATIENT REPORTS PERSISTENT RIGHT HIP PAIN AND EXAMINATION REVEALS TENDERNESS OVER THE GREATER TROCHANTER OF THE RIGHT HIP. ON (B)(6) 2008 PATIENT COMPLAINS OF INCREASED RIGHT HIP PAIN. ADD'L INFO REC'D (B)(6) 2013: PT. HAS BEEN REVISED DUE TO ALLEGED MOM COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    224195 PROFEMUR(R) Z STEM PLASMA SPRAYED HIP COMPONENT, CODE:LPH LPH WRIGHT MEDICAL TECHNOLOGY, INC. 085242470

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention