BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN STRYKER LEFT KNEE

    MDR report key: 2042187 · Received March 29, 2011

    Report

    Report Number
    2249697-2011-00388
    Event Type
    Injury
    Date Received
    March 29, 2011
    Date of Event
    September 8, 2010
    Report Date
    March 8, 2011
    Manufacturer
    STRYKER ORTHOPAEDICS MAHWAH
    Product Code
    JWH
    PMA / PMN Number
    UNK
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PATIENT

    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. ADDITIONAL INFO PERTAINING TO THE DEVICE REFERENCED IN THIS REPORT (INCLUDING X-RAYS AND MEDICAL RECORDS) WAS REQUESTED. IF IT BECOMES AVAILABLE, THE EVAL SUMMARY WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT "PT CALLED TO REPORT THAT SINCE NOVEMBER, HE IS FEELING AN EXTREME AMOUNT OF PAIN, LIKE WALKING ON A MEAT GRINDER. LEG WAS HOT TO THE TOUCH, AND WAS EXPERIENCING HIGH FEVERS. ENDED UP IN HOSPITAL FROM THE HIGH FEVER. PRIMARY CARE PHYSICIAN DR. H. IN SAVANNAH TN, SAID IT WAS A HARDWARE ISSUE IN HIS LEG. HAD A WHITE CELL COUNT DONE AND X-RAY AND THEN SUPER WHITE CELL COUNT AND A BONE SCAN. DREW FLUID OFF THE KNEE CAP AND ALL TEST RESULTS CAME BACK NEGATIVE, NO INFECTION. COULDN'T EXPLAIN FEVERS. WAS 45 DAYS ON ANTIBIOTICS, UNTIL END OF JANUARY. THEN OFF ANTIBIOTICS AND FEVER IS STARTING TO COME BACK. SETTING UP FOR A SECOND OPINION. IN A WHEELCHAIR, CAN WALK SHORT DISTANCE WITH A WALKER."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNKNOWN STRYKER LEFT KNEE IMPLANT JWH STRYKER ORTHOPAEDICS MAHWAH NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Hospitalization| R