BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CUSTOM MRS DISTAL FEMORAL STEM

    MDR report key: 284348 · Received June 26, 2000

    Report

    Report Number
    2219689-2000-00081
    Event Type
    Injury
    Date Received
    June 26, 2000
    Date of Event
    February 12, 2000
    Report Date
    June 26, 2000
    Manufacturer
    HOWMEDICA OSTEONICS
    Product Code
    JDI
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    REVISION SURGERY HAS BEEN REPORTED DUE TO BROKEN STEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CUSTOM MRS DISTAL FEMORAL STEM IMPLANT JDI HOWMEDICA OSTEONICS NA RX99027B

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention