BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SCORPIO NRG CR FEMORAL COMPONENT WITH HA SIZE 4

    MDR report key: 2121370 · Received June 7, 2011

    Report

    Report Number
    2249697-2011-00844
    Event Type
    Injury
    Date Received
    June 7, 2011
    Date of Event
    April 25, 2011
    Report Date
    May 16, 2011
    Manufacturer
    STRYKER ORTHOPAEDICS MAHWAH
    Product Code
    JWH
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    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. IF ADD'L INFO BECOMES AVAILABLE, THE EVAL SUMMARY WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT. THE EVENT INVOLVES A SCORPIO NRG CR FEMORAL COMPONENT WITH HA THAT IS NOT CLEARED FOR COMMERCIAL DISTRIBUTION IN THE US. HOWEVER, THE REPORTED EVENT IS RELATED TO A SUPRACONDYLAR FRACTURE, WHICH MAY OCCUR WITH CEMENTED SCORPIO NRG CR FEMORAL COMPONENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT, "THE PT HAD A SUPRACONDYLAR FRACTURE ON (B)(6) 2011. THEREFORE, THE SURGEON PERFORMED A FIXATION WITH T2 SUPRACONDYLAR NAIL."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SCORPIO NRG CR FEMORAL COMPONENT WITH HA SIZE 4 IMPLANT JWH STRYKER ORTHOPAEDICS MAHWAH NA V71MJA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention