BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SCORPIO-FLEX CR X3 TIBIAL INSERT

    MDR report key: 2150529 · Received June 23, 2011

    Report

    Report Number
    2249697-2011-00937
    Event Type
    Injury
    Date Received
    June 23, 2011
    Date of Event
    February 5, 2010
    Report Date
    June 3, 2011
    Manufacturer
    STRYKER ORTHOPAEDICS MAHWAH
    Product Code
    JWH
    PMA / PMN Number
    K051977
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE FOLLOWING DEVICES WERE ALSO LISTED IN THIS REPORT: SERIES 7000 STANDARD TIBIA: CAT #7115-0011, LOT #MEPMK9. SCORPIO CR M/S FEMUR W/LFIT: CAT #70-5111L, LOT #M9VMME. SCORPIO M-DOME X3 PATELLA: CAT #73-20-0110, LOT #V169. SIMPLEX P SPEEDSET FULL DOSE 1 PACK: CAT #6192-1-001, LOT #DDQ008. IT CANNOT BE DETERMINED WHICH, IF ANY OF THESE DEVICES MAY HAVE CAUSED OR CONTRIBUTED TO THE REPORTED PT PAIN. AN EVAL OF THE DEVICE(S) CANNOT BE PERFORMED AS THE DEVICE(S) WAS NOT RETURNED TO THE MFR. ADDITIONAL INFO (INCLUDING X-RAYS AND MEDICAL RECORDS) WAS REQUESTED. IF ADDITIONAL INFO BECOMES AVAILABLE, THE EVALUATION SUMMARY WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT, "THE PT'S KNEES HAVE NEVER STOPPED HURTING SINCE THE SURGERY. IT HURTS ON BOTH THE OUTER AND INNER PARTS OF THE KNEE. WHEN HE WALKS, IT HURTS ON THE TOP AND BOTTOM OF BOTH KNEES. HE KNEES ARE SWOLLEN ALL OF THE TIME. THE MORE WALKING AND ACTIVITY HE DOES THE MORE SWELLING AND PAIN HE EXPERIENCES. AFTER ACTIVITY AND HE SITS TO RELAX WHILE THE SWELLING OCCURS, HE CAN BARELY BEND THEM IF AT ALL. ANY TIME HE SITS, IT TAKES EVERYTHING HE HAS TO GET UP TO A STANDING POSITION. HE FEELS VERY UNSTABLE ON HIS FEET AS IF THEY ARE TRYING TO BOW INTO EACH OTHER ESPECIALLY WHEN HE STEPS DOWN FROM STEPS. HE HAS MORE PAIN NOW THAN HE HAD BEFORE THE SURGERY." THIS PER IS REPORTING LEFT KNEE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SCORPIO-FLEX CR X3 TIBIAL INSERT IMPLANT JWH STRYKER ORTHOPAEDICS MAHWAH NA MERA04

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Other