BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STRYKER REJUVENATE MODULAR HIP IMPLANT NECK

    MDR report key: 3781005 · Received April 22, 2014

    Report

    Report Number
    3781005
    Event Type
    Injury
    Date Received
    April 22, 2014
    Date of Event
    August 26, 2011
    Report Date
    April 17, 2014
    Manufacturer
    STRYKER ORTHOPAEDICS
    Product Code
    MEH
    Adverse Event
    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) YEAR OLD FEMALE UNDERWENT A TOTAL RIGHT HIP ARTHROPLASTY UNDER DR (B)(6) AT (B)(6) HOSPITAL. A STRYKER REJUVENATE MODULAR NECK AND STEM DEVICE WAS IMPLANTED. PT BECAME SYMPTOMATIC WITH HIP AND WENT TO SEE (B)(6). HIP ASPIRATION WAS DONE ON (B)(6) 2013. ON (B)(6) 2014, PT UNDERWENT REVISION OF RIGHT HIP AND HAD STRYKER REJUVENATE DEVICE EXPLANTED BY DR (B)(6). EXTENSIVE DEBRIDEMENT OF THE JOINT WAS DONE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    244412 STRYKER REJUVENATE MODULAR HIP IMPLANT NECK HIP IMPLANT MEH STRYKER ORTHOPAEDICS 36763601
    244413 STRYKER REJUVENATE MODULAR HIP IMPLANT STEM HIP IMPLANT MEH STRYKER ORTHOPAEDICS MJHK17

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Hospitalization