BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN RIGHT HIP

    MDR report key: 2801442 · Received October 17, 2012

    Report

    Report Number
    2249697-2012-01926
    Event Type
    Injury
    Date Received
    October 17, 2012
    Date of Event
    January 1, 2012
    Report Date
    September 24, 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
    CO, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    AT THIS TIME, THE PATEINT WAS UNABLE TO IDENTIFY THE DEVICES IMPLANTED BUT 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 PATIENT BEGAN HAVING PAIN IN THE RIGHT HIP IN (B)(6) THAT HAS GRADUALLY BEEN INCREASING. SHE EXPERIENCES SHARP PAIN WHEN SHE LIES ON HER RIGHT SIDE. PATIENT SAYS THAT SHE CAN FEEL THE HIP GRINDING AND MOVING BACK AND FORTH WHEN SHE PLACES HER HAND ON HER HIP. PATIENT HAS HAD X-RAYS, BLOOD TESTS FOR COBALT CHROMIUM LEVELS, MR, AND CT SCAN. PATIENT HAD A FOLLOW-UP APPOINTMENT WITH HER DOCTOR ON (B)(6) 2012. THE SURGEON ADVISED HR THAT SHE WILL NEED TO HAVE A REVISION SURGERY. THE SURGEON WILL SCHEDULE THE SURGERY AND CONTACT HER.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 87 YR Other| R