BEUDAMED
    FDA Adverse Event Injury Summary report: N

    R3

    MDR report key: 2964274 · Received February 15, 2013

    Report

    Report Number
    1020279-2013-00102
    Event Type
    Injury
    Date Received
    February 15, 2013
    Date of Event
    February 3, 2013
    Report Date
    February 3, 2013
    Manufacturer
    SMITH&NEPHEW, INC
    Product Code
    JDI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED FOR DISLOCATION. THE FEMORAL HEAD WAS DISASSOCIATED FROM THE LINER. THE EMERGENCY CARE PHYSICIAN ATTEMPTED TO DO A CLOSED REDUCTION TO CORRECT THE INCIDENT; HOWEVER, FRACTURED THE FEMUR. A REVISION SURGERY WAS PERFORMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    69194 R3 R3 CONSTRAINED ACET LINER 52MM JDI SMITH&NEPHEW, INC 12FM03792

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Hospitalization| R 71342200 -FEMORAL HEAD -LOT NO: 10AM04495