BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MRS SML FEM STM 9X102

    MDR report key: 2171357 · Received July 18, 2011

    Report

    Report Number
    9610726-2011-00255
    Event Type
    Injury
    Date Received
    July 18, 2011
    Date of Event
    June 30, 2011
    Report Date
    June 30, 2011
    Manufacturer
    STRYKER ORTHOPAEDICS LIMERICK
    Product Code
    JDI
    PMA / PMN Number
    K952970
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SN
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AN EVAL OF THE DEVICE CANNOT BE PERFORMED AS THE DEVICE WAS NOT RETURNED TO THE MFR. ADD'L INFO WAS REQUESTED. IF IT BECOMES AVAILABLE, THE EVAL SUMMARY WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    PT UNDERWENT TUMOR SURGERY 3 YEARS AGO AND WAS SUFFERING FROM THIGH PAIN RECENTLY. SURGEON FOUND OUT THAT THE STEM WAS FRACTURED INTRA-OP AND MANAGED TO RETRIEVE THE REMAINING OF THE STEM ON PROXIMAL PART OF FEMUR. SURGEON REPLACED WITH NEW CEMENTED STEM (B)(4) AND NEW 60MM EXTENSION PIECE (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MRS SML FEM STM 9X102 IMPLANT JDI STRYKER ORTHOPAEDICS LIMERICK UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 16 YR Required Intervention