BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRIATHLON-PS TIBIAL INSERT #4-11MM

    MDR report key: 1915393 · Received November 17, 2010

    Report

    Report Number
    9610726-2010-00438
    Event Type
    Malfunction
    Date Received
    November 17, 2010
    Date of Event
    October 26, 2010
    Report Date
    November 3, 2010
    Manufacturer
    STRYKER ORTHOPAEDICS LIMERICK
    Product Code
    JWH
    PMA / PMN Number
    K031729
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    WHEN COMPLETED, THE EVALUATION SUMMARY WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT. THIS IS THE SAME PATIENT/EVENT AS MFR # 9610726-2010-00437.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE TKA, THE SURGEON NOTICED A GAP (0.5MM) BETWEEN THE TRIATHLON PS TIBIAL INSERT AND BASEPLATE. THEREFORE, HE REMOVED IT AND IMPLANTED ANOTHER INSERT (#4-11MM) BUT THERE WAS A GAP (0.5MM) BETWEEN THEM AGAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRIATHLON-PS TIBIAL INSERT #4-11MM IMPLANT JWH STRYKER ORTHOPAEDICS LIMERICK NA LBZ459

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Other