BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REJUVENATE

    MDR report key: 2930070 · Received January 23, 2013

    Report

    Report Number
    2930070
    Event Type
    Malfunction
    Date Received
    January 23, 2013
    Date of Event
    January 22, 2013
    Report Date
    January 23, 2013
    Manufacturer
    STRYKER CORPORATION
    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 COMPLAINTS OF PAIN IN RIGHT HIP WHERE SHE HAD A PREVIOUS RIGHT HIP IMPLANT FROM STRYKER USING THE REJUVENATE IMPLANT SYSTEM. SHE ALSO HAD INCREASED LEVELS OF COBALT IN HER BLOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    32481 REJUVENATE IMPLANT, HIP MEH STRYKER CORPORATION * *

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR