BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REJUVENATE

    MDR report key: 3921412 · Received July 2, 2014

    Report

    Report Number
    3921412
    Event Type
    Malfunction
    Date Received
    July 2, 2014
    Date of Event
    June 23, 2014
    Report Date
    July 2, 2014
    Manufacturer
    HOWMEDICA OSTEONICS CORP AKA STRYKER ORTHOPAEDICS
    Product Code
    MEH
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CO, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PATIENT HAD REJUVENATE TOTAL HIP ARTHROPLASTY IN 2011. NOW HAS ELEVATED CHROMIUM AND COBALT LEVELS. RETURNED TO OR TODAY FOR REVISION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    386323 REJUVENATE PROSTHESIS, HIP MEH HOWMEDICA OSTEONICS CORP AKA STRYKER ORTHOPAEDICS * *

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR