BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HIP FRACTURE STEM IMPLANT #1

    MDR report key: 465698 · Received June 11, 2003

    Report

    Report Number
    2219689-2003-00063
    Event Type
    Injury
    Date Received
    June 11, 2003
    Date of Event
    January 13, 2000
    Report Date
    May 15, 2003
    Manufacturer
    HOWMEDICA OSTEONICS CORP.
    Product Code
    KWI
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED TO PFIZER INC., THROUGH PATIENT'S ATTORNEY THAT ALLEGEDLY PATIENT SUSTAINED A FRACTURE OF THE FEMORAL STEM WHICH REQUIRED REVISION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HIP FRACTURE STEM IMPLANT #1 IMPLANT KWI HOWMEDICA OSTEONICS CORP. NA DLIJB

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Required Intervention