BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LINEAGE(R) PC QUAD HEMI FLR STD SHELL

    MDR report key: 1991443 · Received February 15, 2011

    Report

    Report Number
    1043534-2011-00063
    Event Type
    Injury
    Date Received
    February 15, 2011
    Date of Event
    January 13, 2011
    Report Date
    January 14, 2011
    Manufacturer
    WRIGHT MEDICAL TECHNOLOGY, INC.
    Product Code
    LPH
    PMA / PMN Number
    K002149
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION IS NOT COMPLETE. TRENDS WILL BE EVALUATED. THE EVENT CODE IS ADDRESSED IN THE PACKAGE INSERT. 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 1043534-2011-00061, 00062.

    Additional Manufacturer Narrative · 1

    CONCLUSION: NO CONCLUSION CAN BE DRAWN. COMPLAINT REVIEWED AND ANALYSIS SHOWED NO TREND FOR 36430050 LOT NO: 10491719. DEVICE HISTORY RECORD REVIEWED. PACKAGE INSERT REVIEWED. PRODUCT NOT RETURNED.

    Description of Event or Problem · 1

    ALLEGEDLY REVISED DUE TO DISLOCATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LINEAGE(R) PC QUAD HEMI FLR STD SHELL HIP COMPONENT LPH WRIGHT MEDICAL TECHNOLOGY, INC. 10491719

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Hospitalization| R