BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRIATHLON PS X3 TIBIAL INSERT

    MDR report key: 1850368 · Received September 20, 2010

    Report

    Report Number
    9610726-2010-00322
    Event Type
    Malfunction
    Date Received
    September 20, 2010
    Date of Event
    September 2, 2010
    Report Date
    September 2, 2010
    Manufacturer
    STRYKER ORTHOPAEDICS LIMERICK
    Product Code
    JWH
    PMA / PMN Number
    K051146
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    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 # 9610726-2010-00321.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT, "NEITHER INSERT WOULD SEAT PROPERLY. THE FRONT WOULD SEAT BUT NOT THE BACK."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRIATHLON PS X3 TIBIAL INSERT IMPLANT JWH STRYKER ORTHOPAEDICS LIMERICK NA MJL1JM

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Other