BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN RIGHT REJUVENATE HIP

    MDR report key: 2801349 · Received October 17, 2012

    Report

    Report Number
    2249697-2012-01887
    Event Type
    Injury
    Date Received
    October 17, 2012
    Date of Event
    June 1, 2012
    Report Date
    September 28, 2012
    Manufacturer
    STRYKER ORTHOPAEDICS MAHWAH
    Product Code
    MEH
    PMA / PMN Number
    UNK
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IF RECEIVED WILL BE PROVIDED IN A SUPPLEMENTAL REPORT. AT THIS TIME, THE PATIENT WAS UNABLE TO IDENTIFY THE DEVICES IMPLANTED, HOWEVER BELIEVES THEM TO BE EITHER REJUVENATE OR ABG II. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IF RECEIVED, WILL BE PROVIDED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAS A HARD TIME GOING UP STEPS AND WALKING DUE TO PAIN. SHE ALSO STATES THAT SHE CANNOT PUT PRESSURE ON THE LEFT LEG OR LIE ON IT WHEN SLEEPING. SHE HAS BEEN HAVING THE PROBLEM FOR QUITE SOME TIME, BUT CANNOT PINPOINT THE SPECIFIC ONSET. THE PATIENT COMPLETED BLOOD WORK AND HAD X-RAYS DURING HER DOCTOR'S APPOINTMENT ON (B)(6) 2012. SHE IS SCHEDULED TO HAVE AN MRI NEXT WEEK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNKNOWN RIGHT REJUVENATE HIP IMPLANT MEH STRYKER ORTHOPAEDICS MAHWAH NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Other