BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SCORPIO NRG CR FEMORAL COMPONENT RIGHT #7

    MDR report key: 1942436 · Received December 22, 2010

    Report

    Report Number
    2249697-2010-01856
    Event Type
    Injury
    Date Received
    December 22, 2010
    Date of Event
    November 12, 2010
    Report Date
    November 12, 2010
    Manufacturer
    STRYKER ORTHOPAEDICS MAHWAH
    Product Code
    JWH
    PMA / PMN Number
    K042343
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AN EVAL OF THE DEVICE CANNOT BE PERFORMED AS THE DEVICE REMAINED IMPLANTED IN THE PT AND WAS NOT RETURNED TO THE MFR. ADD'L INFO PERTAINING TO THE DEVICE REFERENCED IN THIS REPORT (INCLUDING X-RAYS AND MEDICAL RECORDS) WAS REQUESTED. IF IT BECOMES AVAILABLE, THE EVAL SUMMARY WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT, "AFTER FOLLOWING ST. CLOUD HOSPITAL'S VERIFICATION PROCEDURE, THE STAFF OPENED AND IMPLANTED #7 RIGHT FEMUR ON PT'S LEFT FEMUR. ERROR WAS NOTICED DURING CONTRALATERAL PROCEDURE AND WAS REVISED IMMEDIATELY."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SCORPIO NRG CR FEMORAL COMPONENT RIGHT #7 IMPLANT JWH STRYKER ORTHOPAEDICS MAHWAH NA UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention