BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN RIGHT HIP

    MDR report key: 2801444 · Received October 17, 2012

    Report

    Report Number
    2249697-2012-01925
    Event Type
    Injury
    Date Received
    October 17, 2012
    Date of Event
    April 12, 2011
    Report Date
    September 24, 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
    WI, US
    Reporter Occupation
    PATIENT

    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 PATIENT ASKED US TO EXPLAIN THE RECENT LETTER SHE JUST RECEIVED FROM HER DOCTOR SAYING THAT HER HIP IMPLANT HAD BEEN RECALLED. THE PATIENT STATES, SHE HAS BEEN IN TREMENDOUS PAIN FOR A LONG TIME. SHE STATED, SHE WAS HOSPITALIZED IN (B)(6) 2012 WITH A SEVERE INFECTION IN HER HIP. SHE ALSO STATED, THERE IS A LARGE HOLE/INDENTATION IN HER HIP AT THE SITE OF IMPLANT.

    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 56 YR Other