BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    X3 TRIATHLON CS INS SIZE1 9MM

    MDR report key: 2142653 · Received June 21, 2011

    Report

    Report Number
    9610726-2011-00218
    Event Type
    Malfunction
    Date Received
    June 21, 2011
    Date of Event
    June 1, 2011
    Report Date
    June 1, 2011
    Manufacturer
    STRYKER ORTHOPAEDICS LIMERICK
    Product Code
    JWH
    PMA / PMN Number
    K063423
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, 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. IF DEVICE OR ADDITIONAL INFORMATION BECOMES AVAILABLE, THE EVALUATION SUMMARY WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT. THIS IS THE SAME PATIENT/EVENT AS MFR # 2249697-2011-00931.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT, "IMPLANTED #1 9MM CS INSERT AFTER CEMENT HARDENED, THE KNEE WAS A LITTLE LOOSE IN FLEXION/EXTENSION. DR. (B)(6) EXPLANTED #1 9MM IMPLANT. THERE WAS NO CONCERN WITH THE IMPLANT ITSELF. THE DOCTOR THEN PUT A #1 11MM CS INSERT TRIAL IN THE PATIENT. THE CS #1 11MM INSERT TRIAL CRACKED."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 X3 TRIATHLON CS INS SIZE1 9MM IMPLANT JWH STRYKER ORTHOPAEDICS LIMERICK NA LAP867

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Other