BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SIZE 3-6 CR FEMORAL AND TIBIAL TRIALING - UPPER TR

    MDR report key: 1193510 · Received October 8, 2008

    Report

    Report Number
    2249697-2008-00305
    Event Type
    Malfunction
    Date Received
    October 8, 2008
    Date of Event
    September 9, 2008
    Report Date
    September 9, 2008
    Manufacturer
    STRYKER ORTHOPAEDICS MAHWAH
    Product Code
    LXH
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE NOT RETURNED AS IT IS IN THE LOANERS KIT. NO EVALUATION WILL BE PERFORMED. SHOULD DEVICE BECOME AVAILABLE WITH ADDITIONAL INFO, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT, "CUTS WERE MADE IN THE USUAL FASHION. TRIALS WAS SEATED CORRECTLY AND FLUSH THE CUTS. VARUS/VALGUS TESTING AND RANGE OF MOTION TESTING REVEALED THE TRIAL COMPONENTS WERE TOO 'TIGHT' AND A 2MM CUT WAS TAKEN FROM THE TIBIA IN BOTH KNEES. TRIAL COMPONENTS WERE RETESTED AND FOUND TO STILL BE 'TIGHT' BUT SATISFACTORY. VARUS/VALGUS TESTING AND RANGE OF MOTION TESTING OF THE FINAL COMPONENTS REVEALED THE COMPONENT TO BE SOMEWHAT LOOSE, BUT STILL JUST SATISFACTORY."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SIZE 3-6 CR FEMORAL AND TIBIAL TRIALING - UPPER TR INSTRUMENT LXH STRYKER ORTHOPAEDICS MAHWAH NA 1324971

    Patients

    Seq Age Sex Outcome Treatment
    1 NI Other