BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OSTEONICS ODC HIP STEM

    MDR report key: 354920 · Received October 1, 2001

    Report

    Report Number
    2243265-2001-00090
    Event Type
    Injury
    Date Received
    October 1, 2001
    Date of Event
    August 31, 2001
    Report Date
    August 31, 2001
    Manufacturer
    HOWMEDICA OSTEONICS
    Product Code
    KWY
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    REVISION SURGERY PERFORMED TO REMOVE AN OSTEONICS ODC STEM THAT WAS LOOSE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    44580 OSTEONICS ODC HIP STEM IMPLANT KWY HOWMEDICA OSTEONICS NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention