BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN RIGHT ABGII HIP

    MDR report key: 2833008 · Received October 30, 2012

    Report

    Report Number
    9616680-2012-00963
    Event Type
    Injury
    Date Received
    October 30, 2012
    Date of Event
    March 5, 2012
    Report Date
    October 16, 2012
    Manufacturer
    STRYKER IRELAND, LTD. OSTEONICS (ORTHOPAEDICS DIVI
    Product Code
    JDI
    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

    ADD'L INFO 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 BEEN EXPERIENCING SWELLING ON HIS BUTTOCK AREA AND HAS BEEN HAVING PAIN ON THE INNER SIDE OF HIS THIGH. PT REPORTS THAT HE HAS HAD X-RAYS AND THE DOCTOR WANTS HIM TO HAVE AN MRI.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNKNOWN RIGHT ABGII HIP IMPLANT JDI STRYKER IRELAND, LTD. OSTEONICS (ORTHOPAEDICS DIVI NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Other