BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN DEPUY STEM

    MDR report key: 2970249 · Received February 20, 2013

    Report

    Report Number
    1818910-2013-03977
    Event Type
    Injury
    Date Received
    February 20, 2013
    Date of Event
    September 25, 2012
    Report Date
    February 8, 2013
    Manufacturer
    DEPUY FRANCE
    Product Code
    KWA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINT HAS BEEN REOPENED BECAUSE PRODUCT INFORMATION HAS BEEN RECEIVED WHICH MAY CHANGE THE INVESTIGATION FOR THE STEM.

    Description of Event or Problem · 1

    CLINICAL REPORT STATES THE PATIENT WAS REVISED TO ADDRESS METALLOSIS AND HIGH CHROMIUM AND COBALT LEVELS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    73533 UNKNOWN DEPUY STEM STEM KWA DEPUY FRANCE UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Male Required Intervention