BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN LEFT HIP

    MDR report key: 2831101 · Received November 2, 2012

    Report

    Report Number
    2249697-2012-02144
    Event Type
    Injury
    Date Received
    November 2, 2012
    Date of Event
    September 6, 2011
    Report Date
    October 12, 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
    IL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    AT THIS TIME, THE PT WAS UNABLE TO IDENTIFY THE DEVICE IMPLANTED BUT BELIEVES THEM TO BE EITHER REJUVENATE OR ABG II. ADDITIONAL 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 PT IS EXPERIENCING SEVERE PAIN AND IS ONLY ABLE TO SLEEP ON HER STOMACH. PT IS REPORTING THAT SHE IS HAVING TROUBLE WALKING AND IS EXPERIENCING PAIN DOWN TO THE KNEE. THE PT IS STATING THAT SHE HAS PAIN AND PINCHING IN HER BUTTOCK AREA. PT IS ALSO EXPERIENCING TENDERNESS.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Other