BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SIMPLEX P - CE TOBRA FD 10-PK

    MDR report key: 1489452 · Received August 13, 2009

    Report

    Report Number
    9610726-2009-00165
    Event Type
    Malfunction
    Date Received
    August 13, 2009
    Date of Event
    July 21, 2009
    Report Date
    July 21, 2009
    Manufacturer
    STRYKER ORTHOPAEDICS LIMERICK
    Product Code
    LOD
    PMA / PMN Number
    K014199
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT TWO SEPARATE MIXES OF CEMENT BY THE SAME SCRUB NURSE, IN THE SAME THEATRE ON THE SAME DAY WITH THE SAME SURGEON, FAILED TO BEHAVE AS EXPECTED. THERE APPEARED TO BE NO CLEAR DOUGH TIME MAKING THE MIX EXTREMELY HARD TO WORK WITH AS IT REMAINED RUNNY THROUGHOUT THE TIMEFRAME USUALLY GIVEN FOR WORKING TIME. THUS MAKING PRESSURIZATION OF THE FEMORAL STEM ALMOST IMPOSSIBLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SIMPLEX P - CE TOBRA FD 10-PK IMPLANT LOD STRYKER ORTHOPAEDICS LIMERICK NA TEQ033

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other