BEUDAMED
    FDA Adverse Event Summary report: N

    STRYKER REJUVENATE

    MDR report key: 3437523 · Received October 24, 2013

    Report

    Report Number
    3437523
    Date Received
    October 24, 2013
    Date of Event
    March 2, 2012
    Report Date
    October 24, 2013
    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

    (B)(6) 2012: THIS (B)(6) YEAR OLD MALE UNDERWENT A TOTAL RIGHT HIP ARTHROPLASTY UNDER DR. (B)(6). A STRYKER REJUVENATE MODULAR STEM AND NECK DEVICE WAS IMPLANTED. THIS HAD HIP REPLACEMENT AS SUCH A YOUNG AGE DUE TO MED HAX OF SEVERE PERTHES DISEASE. PATIENT BECAME SYMPTOMATIC WITH HIS HIP AND WENT TO SEE DR. (B)(6). RIGHT HIP ASPIRATION WAS DONE ON (B)(6) 2013. PATIENT UNDERWENT REVISION OF THE RIGHT HIP AND HAD THE 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
    546109 STRYKER REJUVENATE HIP IMPLANT MEH STRYKER ORTHOPAEDICS 38846002

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR Hospitalization| R