BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SCORPIO FIXED BPLATE PA SIZE 7

    MDR report key: 1932978 · Received December 15, 2010

    Report

    Report Number
    9610726-2010-00471
    Event Type
    Injury
    Date Received
    December 15, 2010
    Date of Event
    November 30, 2010
    Report Date
    November 30, 2010
    Manufacturer
    STRYKER ORTHOPAEDICS LIMERICK
    Product Code
    MBH
    PMA / PMN Number
    K033971
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    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

    REVISION OF A SCORPIO NRG PRIMARY FROM (B)(6) 2007 FOR PAIN. REVISION DIAGNOSIS WAS TIBIAL LOOSENING. SURGEON EXPLAINED THAT PATIENT HAD BEEN EXPERIENCING PAIN FOR A LONG TIME. HAS CARRIED OUT A KNEE ARTHROSCOPY AND SYNOVECTOMY ON THIS KNEE. IN 2009, HE CHANGED THE SCORPIO CR POLY INSERT TO A SLIGHTLY THICKER ONE AND RESURFACED THE PATELLA. ACCORDING TO THE SURGEON, THE PATIENT WAS STILL EXPERIENCING PAIN. HE DISCUSSED THAT ON THE X-RAY, THE IMPLANTS ALL LOOKED GOOD. DURING THIS REVISION, HE REMOVED THE FEMORAL AND TIBIAL COMPONENT. HE FELT THAT THE TIBIA CAME OUT EASILY AND THAT IT WAS LOOSE. HE REPLACED THE HA COATED SCORPIO FEMUR AND TIBIA WITH CEMENTED NRG CR FEMUR AND BASEPLATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SCORPIO FIXED BPLATE PA SIZE 7 IMPLANT MBH STRYKER ORTHOPAEDICS LIMERICK NA J35MED

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention