BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIOMET

    MDR report key: 505203 · Received January 7, 2004

    Report

    Report Number
    505203
    Event Type
    Injury
    Date Received
    January 7, 2004
    Date of Event
    October 17, 2002
    Report Date
    September 8, 2003
    Manufacturer
    BIOMET
    Product Code
    JDS
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    SD, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    S/P INTRAMEDULLARY NAILING OF THE RIGHT FEMOR APPROX 1. PT NOW HAS COMPLAINTS OF PAIN ABOUT THE RIGHT KNEE. X-RAYS SHOWED A NON-UNION OF THE PROXIMAL 3RD OF THE FEMUR WHERE THE ORIGINAL FRACTURE SITE HAD BEEN. THERE IS A FRACTURE THRU THE IM NAIL WITH AUTOGENOUS BONE GRAFT IN THE SITE. AN IMPLANTABLE BONE STIMULATOR WILL BE PLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BIOMET FEMORAL NAIL JDS BIOMET 341236 834740
    2 BIOMET HEX HEAD SCREW X2 HWC BIOMET 33-345428 180530
    3 BIOMET HEX HEAD SCREW X2 HWC BIOMET 33-345534 9347160

    Patients

    Seq Age Sex Outcome Treatment
    1 21 YR Required Intervention