BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN RIGHT HIP

    MDR report key: 2821379 · Received October 23, 2012

    Report

    Report Number
    2249697-2012-01975
    Event Type
    Injury
    Date Received
    October 23, 2012
    Date of Event
    November 14, 2011
    Report Date
    October 2, 2012
    Manufacturer
    STRYKER ORTHOPAEDICS MAHWAH
    Product Code
    JDI
    PMA / PMN Number
    UNK
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    AT THIS TIME, THE PATIENT 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 THE PATIENT RETURNED TO DOCTOR TWO WEEKS AGO IN PAIN. PATIENT STATES THAT SHE HAD X-RAYS DONE. PATIENT ALSO STATES THAT DOCTOR GAVE HER PRESCRIPTION FOR PHYSICAL THERAPY FOR SIX WEEKS WHICH SHE HAS ALREADY COMPLETED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Other