BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNERGY

    MDR report key: 2011114 · Received March 8, 2011

    Report

    Report Number
    1020279-2011-00065
    Event Type
    Injury
    Date Received
    March 8, 2011
    Date of Event
    February 8, 2011
    Report Date
    March 8, 2011
    Manufacturer
    SMITH AND NEPHEW, INC
    Product Code
    LPH
    PMA / PMN Number
    K963509
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A REVISION WAS PERFORMED DUE TO OSTEOLYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNERGY HIP STEM LPH SMITH AND NEPHEW, INC 90400644

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Hospitalization