BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CONSERVE(R) TOTAL FEMORAL HEAD W/BFH

    MDR report key: 2993362 · Received March 7, 2013

    Report

    Report Number
    1043534-2013-00493
    Event Type
    Injury
    Date Received
    March 7, 2013
    Report Date
    March 6, 2013
    Manufacturer
    WRIGHT MEDICAL TECHNOLOGY, INC.
    Product Code
    KWA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCLUSION: NO DEVICE FAILURE.THE COMPLAINT WAS REVIEWED AND ANALYSIS SHOWED NO TREND FOR ITEM/LOT. THE PACKAGE INSERT WAS ALSO REVIEWED. THE PRODUCT WAS NOT RETURNED.(B)(4).

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION IS NOT COMPLETE. TRENDS WILL BE EVALUATED. NO COMPLAINT WAS STATED AGAINST THIS DEVICE. THIS REPORT WILL BE UPDATED WHEN THE INVESTIGATION IS COMPLETE. THIS IS THE SAME EVENT AS 1043534-2013-00232, 00492.

    Description of Event or Problem · 1

    ALLEGEDLY PER GEORGIOU, C. ET AL., OPEN ORTHOP J. 2012; 6:593-600, "DOES CHOICE OF HEAD SIZE AND NECK GEOMETRY AFFECT STEM MIGRATION IN MODULAR LARGE-DIAMETER METAL-ON-METAL TOTAL HIP ARTHROPLASTY? A PRELIMINARY ANALYSIS." "ONE HAD A STEM REVISION BECAUSE OF ASEPTIC LOOSENING, WHICH WAS ATTRIBUTED TO FAILURE OF PRIMARY FIXATION OF THE UNDERSIZED STEM." NO DETAILS OF THE PATIENT OR REVISION WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    97292 CONSERVE(R) TOTAL FEMORAL HEAD W/BFH HIP COMPONENT, CODE:KWA KWA WRIGHT MEDICAL TECHNOLOGY, INC. NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention