BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REJUVENATE

    MDR report key: 3121582 · Received May 17, 2013

    Report

    Report Number
    3121582
    Event Type
    Malfunction
    Date Received
    May 17, 2013
    Date of Event
    May 15, 2013
    Report Date
    May 17, 2013
    Manufacturer
    HOWMEDICA OSTEONICS CORP
    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 TAKEN TO OR FOR FAILED RIGHT TOTAL HIP ARTHROPLASTY. REVISION OF THE HIP PERFORMED. STRYKER REJUVENATE SPT MODULAR STEM WAS ORIGINAL HARDWARE AND PART OF RECALL.WHAT WAS THE ORIGINAL INTENDED PROCEDURE?HIP REVISION.DEVICE #1IS THIS A LABORATORY DEVICE OR LABORATORY TEST?NO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    219454 REJUVENATE IMPLANT, HIP MEH HOWMEDICA OSTEONICS CORP MKTDTR *

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR