BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STRYKER ORTHOPAEDICS

    MDR report key: 3170580 · Received May 7, 2013

    Report

    Report Number
    3170580
    Event Type
    Injury
    Date Received
    May 7, 2013
    Date of Event
    May 6, 2013
    Report Date
    May 7, 2013
    Manufacturer
    STRYKER ORTHOPAEDICS
    Product Code
    MEH
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    TX, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2011 - THIS (B)(6) FEMALE UNDERWENT A TOTAL RIGHT HIP ARTHROPLASTY. A STRYKER REJUVENATE MODULAR STEM AND NECK DEVICE WAS IMPLANTED. ON 06/28/2012 - STRYKER ISSUED A VOLUNTARY RECALL OF THE A STRYKER REJUVENATE MODULAR STEM AND NECK. A REACTIVE ISSUE AND CORROSIVE PHENOMENON HAD BEEN DETERMINED TO AFFECT SOME OF THE PATIENTS WITH THE IMPLANT. THE CONCERN IS FOR CHROMIUM AND COBALT FRETTING OUT INTO THE TISSUES OF THE AFFECTED PATIENTS CAUSING SEVERE TISSUE DAMAGE. ON (B)(6) 2013 - PATIENT UNDERWENT REVISION OF THE RIGHT HIP AND HAD THE STRYKER REJUVENATE DEVICE EXPLANTED. EXTENSIVE DEBRIDEMENT OF THE JOINT WAS DONE. HIP IMPLANT REVISED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    199996 STRYKER ORTHOPAEDICS REJUVENATE MODULAR HIP IMPLANT MEH STRYKER ORTHOPAEDICS 37106302

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Required Intervention