BEUDAMED
    FDA Adverse Event Injury Summary report: N

    X3 TRIATHLON CS INSERT #5 9MM

    MDR report key: 2162197 · Received July 7, 2011

    Report

    Report Number
    9610726-2011-00236
    Event Type
    Injury
    Date Received
    July 7, 2011
    Date of Event
    June 15, 2011
    Report Date
    June 15, 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
    AR, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AN EVALUATION OF THE DEVICE CANNOT BE PERFORMED AS THE DEVICE WAS NOT RETURNED TO THE MANUFACTURER. ADDITIONAL INFORMATION WAS REQUESTED. IF IT BECOMES AVAILABLE, THE EVALUATION SUMMARY WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT, "PATIENT WAS REVISED DUE TO PAIN AND LACK OF RANGE OF MOTION. X-RAYS SHOW LEFT KNEE REPLACEMENT IN GOOD POSITION & A LARGE POSTERIOR OSTEOPHYTE ON THE FEMUR IN THE LATERAL VIEW. PRIMARY IMPLANTS WERE WELL FIXED, BUT HAD TO BE REMOVED IN ORDER TO REMOVE OSTEOPHYTE. A REVISION TIBIA WITH STEM AND A PRIMARY CR FEMUR WAS IMPLANTED FOR THE REVISION. PRIMARY IMPLANTS PERFORMED AS EXPECTED, REVISION WAS DUE TO BONE THAT WAS NOT REMOVED DURING THE PRIMARY SURGERY."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 X3 TRIATHLON CS INSERT #5 9MM IMPLANT JWH STRYKER ORTHOPAEDICS LIMERICK NA LBD678

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Required Intervention