BEUDAMED
    FDA Adverse Event Injury Summary report: N

    X3 TRIATHLON CS INSERT #3 9MM

    MDR report key: 2062733 · Received April 13, 2011

    Report

    Report Number
    9610726-2011-00101
    Event Type
    Injury
    Date Received
    April 13, 2011
    Date of Event
    February 12, 2010
    Report Date
    March 14, 2011
    Manufacturer
    STRYKER ORTHOPAEDICS LIMERICK
    Product Code
    JWH
    PMA / PMN Number
    K063423
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE FOLLOWING OTHER DEVICES WERE ALSO LISTED IN THIS REPORT: FEMORAL COMPONENT CEMENTED #4 RIGHT: CAT# 5510-F-402, LOT# SRAKY. TRIATHLON PRIM TIB BASEPLATE CEMENTED: CAT# 5520-B-300 LOT# AGNL. TRIATHLON ASYMMETRIC X3 PATELLA: CAT# 5551-G-320 LOT# 0D40. AT THE PRESENT TIME IT CANNOT BE DETERMINED WHICH, IF ANY OF THESE DEVICES MAY HAVE CAUSED OR CONTRIBUTED TO THE PT'S PAIN. 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 (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 ASKING IF HER KNEE WAS ON RECALL. HAS HAD PAIN SINCE THE SURGERY, 24/7 AND IT IS GETTING WORSE AND WORSE. DR. IS NOT FINDING REASONS FOR THE PAIN. DR. SAID THAT HE WOULD HAVE TO GO BACK IN TO SEE WHAT IS GOING ON WRONG. PT STATED SHE CANNOT BEND HER KNEE PAST 65-70 DEGREES. LOOSES HER BALANCE AND HAS TO WALK WITH A CANE. HURTS SITTING DOWN AS WELL. FEELS LIKE IT IS PULLING."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 X3 TRIATHLON CS INSERT #3 9MM IMPLANT JWH STRYKER ORTHOPAEDICS LIMERICK NA LBM042

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Other