BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SCORPIO NRG CR FEMORAL COMPONENT RIGHT #7

    MDR report key: 2948591 · Received February 7, 2013

    Report

    Report Number
    0002249697-2013-00583
    Event Type
    Injury
    Date Received
    February 7, 2013
    Date of Event
    May 16, 2012
    Report Date
    January 28, 2013
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    MEH
    PMA / PMN Number
    K042343
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    PHYSICIAN ASSISTANT

    Narratives

    Additional Manufacturer Narrative · 1

    CATALOGUE NUMBER UNKNOWN AT THIS TIME. DEVICE DESCRIPTION REPORTED AS UNKNOWN SCORPIO NRG. AN EVALUATION OF THE DEVICE CANNOT BE PERFORMED AS THE DEVICE WAS NOT RETURNED TO THE MANUFACTURER. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, IT WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT. DEVICE NOT RETURNED TO MANUFACTURER.

    Description of Event or Problem · 1

    THE CLINICAL RESEARCH ASSOCIATE, (B)(6), REPORTED THAT THE PATIENT WHO IS A SUBJECT IN THE (B)(4) CLINICAL STUDY IN THE (B)(6), UNDERWENT A TOTAL KNEE ARTHROPLASTY ON (B)(6) 2012. THE CLINICAL RESEARCH ASSOCIATE REPORTED THAT THE PATIENT SUFFERED FROM AN IMMOBILISATION PROBLEM ON (B)(6) 2012 AND LATER UNDERWENT AN ARTHROSCOPIC RELEASE PROCEDURE ON (B)(6) 2012. THE PATIENT WAS DISCHARGED ON (B)(6) 2012 AND THE CLINICAL RESEARCH ASSOCIATE REPORTED THAT THE PATIENT HAS SINCE RECOVERED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    52544 SCORPIO NRG CR FEMORAL COMPONENT RIGHT #7 IMPLANT MEH STRYKER ORTHOPAEDICS-MAHWAH MKJY5K

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Required Intervention