BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SCORPIO PS BASIC FEMUR

    MDR report key: 2831057 · Received November 2, 2012

    Report

    Report Number
    2249697-2012-02142
    Event Type
    Injury
    Date Received
    November 2, 2012
    Report Date
    October 16, 2012
    Manufacturer
    STRYKER ORTHOPAEDICS MAHWAH
    Product Code
    MEH
    PMA / PMN Number
    K962152
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IF RECEIVED WILL BE PROVIDED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT, EXPLANTED FEMORAL COMPONENT AND POLY DUE TO LOOSENING AND FAILURE PER MD. EXPLANTS SENT TO BIOMED. PT STATUS POST RIGHT TOTAL KNEE REPLACEMENT PERFORMED A LITTLE OVER TWO YEARS AGO. THE PT HAS HAD A PERSISTENT KNEE PAIN AND EFFUSION ON THE RIGHT SIDE. HE HAS A LEFT TOTAL KNEE REPLACEMENT WHICH HE IS VERY PLEASED WITH. MORE RECENTLY, HE HAS DESCRIBED MECHANICAL SYMPTOMS AND CLUNKING IN THE KNEE. THIS HAS LEAD TO HIM HAVING PERIODS AND EPISODES OF INSTABILITY WITH THE RIGHT KNEE. RADIOGRAPHICALLY, THE COMPONENTS APPEAR TO BE WELL ALIGNED, IN GOOD POSITION, AND WITHOUT EVIDENCE OF LOOSENING. THE KNEE WAS ASPIRATED AS WELL AS ESR (ERYTHROCYTE SEDIMENTATION RATE) AND CRP (C-REACTIVE PROTEIN) DRAWN WHICH WERE NEGATIVE FOR ANY SIGNS OF INFECTED ARTHROPLASTY. DESPITE HIS NEGATIVE WORKUP, THE PT WAS HAVING SIGNIFICANT DISABILITY AND COULD NOT GO ON LIVING WITH THESE TYPES OF SYMPTOMS, AND HE WAS OFFERED A REVISION OF HIS RIGHT TOTAL KNEE ARTHROPLASTY WITH AN EXPLORATORY-TYPE SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SCORPIO PS BASIC FEMUR IMPLANT MEH STRYKER ORTHOPAEDICS MAHWAH NA MHELEW

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Required Intervention