BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CONSERVE(R) TOTAL HEAD W/BFH

    MDR report key: 3122262 · Received May 21, 2013

    Report

    Report Number
    1043534-2013-00821
    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
    KWA
    PMA / PMN Number
    K021349
    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, 00822, 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) 20606, 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)(4) 13: PT. HAS BEEN REVISED DUE TO ALLEGED MOM COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    224413 CONSERVE(R) TOTAL HEAD W/BFH HIP COMPONENT, CODE:KWA KWA WRIGHT MEDICAL TECHNOLOGY, INC. 085260576

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention