BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DEPUY

    MDR report key: 499854 · Received December 5, 2003

    Report

    Report Number
    499854
    Event Type
    Injury
    Date Received
    December 5, 2003
    Date of Event
    September 17, 2003
    Report Date
    November 5, 2003
    Manufacturer
    DE PUY
    Product Code
    LPH
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    PA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PT WITH DEGENERATIVE ARTHRITIS OF THE LEFT HIP WAS UNDERGOING A TOTAL HIP REPLACEMENT. DURING INSERTION OF A 6.3MM TRI-LOCK BROACH, A SMALL CRACK WAS MADE IN THE CALCAR. TWO CABLES WERE PLACED AROUND THE PROXIMAL FEMUR AND THE OPERATION WAS COMPLETED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DEPUY 6.3MM TRI-LOCK BROACH LPH DE PUY UNK WG7H7 1001

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Required Intervention