BEUDAMED
    FDA Adverse Event Summary report: N

    STRYKER REJUVENATE MODULAR STEM IMPLANT

    MDR report key: 3092153 · Received April 29, 2013

    Report

    Report Number
    MW5030011
    Date Received
    April 29, 2013
    Date of Event
    April 3, 2013
    Report Date
    April 29, 2013
    Manufacturer
    STRYKER ORTHOPAEDICS
    Product Code
    MEH
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TX, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2011, PT HAD STRYKER REJUVENATE MODULAR NECK AND STEM PLACED IN RIGHT HIP FOR TOTAL ARTHROPLASTY. ON (B)(6) 2012, STRYKER ISSUED VOLUNTARY RECALL OF STRYKER REJUVENATE MODULAR NECK AND STEM. ON (B)(6) 2013, PT HAD THE REJUVENATE HARDWARE EXPLANTED AND UNDERWENT REVISION OF TOTAL HIP ARTHROPLASTY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    184259 STRYKER REJUVENATE MODULAR STEM IMPLANT HIP IMPLANT DEVICE MEH STRYKER ORTHOPAEDICS
    184281 STRYKER REJUVENATE MODULAR NECK HIP IMPLANT DEVICE MEH STRYKER ORTHOPAEDICS MHLPTW

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Hospitalization