BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FOUNDATION HIP SYSTEM

    MDR report key: 364337 · Received December 6, 2001

    Report

    Report Number
    1644408-2001-00022
    Event Type
    Injury
    Date Received
    December 6, 2001
    Date of Event
    November 21, 2001
    Report Date
    December 6, 2001
    Manufacturer
    ENCORE ORTHOPEDICS, INC.
    Product Code
    LPH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    FEMORAL FRACTURE DUE TO IMPROPER SURGICAL PROCEDURE. FEMORAL CANAL PREPARED WITH BROACH ONE SIZE SMALLER THAN FEMORAL STEM IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    54941 FOUNDATION HIP SYSTEM FOUNDATION HIP STEM LPH ENCORE ORTHOPEDICS, INC. * 596191

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other