BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SCORPIO NRG PS FEMORAL #5 RIGHT

    MDR report key: 3033652 · Received April 3, 2013

    Report

    Report Number
    0002249697-2013-01189
    Event Type
    Injury
    Date Received
    April 3, 2013
    Date of Event
    March 13, 2013
    Report Date
    March 13, 2013
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    JWH
    PMA / PMN Number
    K030978
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AN EVENT REGARDING A DISTAL FEMUR FRACTURE DURING IMPLANTATION OF A SCORPIO NRG PS FEMORAL #5 RIGHT WAS REPORTED. THE EVENT WAS NOT CONFIRMED. A DEVICE HISTORY REVIEW CONFIRMED ALL DEVICES WERE MANUFACTURED AND ACCEPTED INTO FINISHED GOODS WITH NO REPORTED DISCREPANCIES. A COMPLAINT HISTORY REVIEW CONFIRMED NO SIMILAR EVENTS FOR THE REPORTED LOT. THE EXACT CAUSE OF THE EVENT COULD NOT BE DETERMINED BECAUSE OF A LACK OF INFORMATION. FURTHER INFORMATION SUCH AS MEDICAL RECORDS AND LEGIBLE X-RAYS ARE NEEDED TO COMPLETE THE INVESTIGATION FOR DETERMINING THE ROOT CAUSE.

    Additional Manufacturer Narrative · 1

    CATALOGUE NUMBER UNKNOWN AT THIS TIME. DEVICE DESCRIPTION REPORTED AS UNKNOWN 81-440XX SCORPIO NRG PS FEMORAL #X XXXX. WHEN COMPLETED, THE EVALUATION SUMMARY WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DISTAL FEMUR WAS BROKEN DURING IMPACTING FEMORAL COMPONENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DISTAL FEMUR WAS BROKEN DURING IMPACTING FEMORAL COMPONENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    136329 SCORPIO NRG PS FEMORAL #5 RIGHT IMPLANT JWH STRYKER ORTHOPAEDICS-MAHWAH MLP4ML

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Required Intervention