BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SIMPLEX P - US TOBRA FD 10-PK

    MDR report key: 1760180 · Received July 12, 2010

    Report

    Report Number
    9610726-2010-00224
    Event Type
    Malfunction
    Date Received
    July 12, 2010
    Date of Event
    June 23, 2010
    Report Date
    June 23, 2010
    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

    Additional Manufacturer Narrative · 1

    AN EVALUATION OF THE DEVICE CANNOT BE PERFORMED AS THE DEVICE WAS NOT RETURNED TO THE MANUFACTURER. ADDITIONAL INFORMATION PERTAINING TO THE DEVICE(S) REFERENCED IN THIS REPORT WAS REQUESTED. IF IT BECOMES AVAILABLE, THE EVALUATION SUMMARY WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED, "THE SCRUB NURSE MIXED THE CEMENT MONOMER AND POLYMER WITH A SUCTION CANNULA WHICH IS MADE OF PLASTIC AND THEN POURED INTO CEMENT GUN CHAMBER FOR USE FOR AN EXETER STEM. THE SURGEON INJECTS THE CEMENT INTO THE FEMORAL CANAL AT 3 MINS AND COMPLAINED THAT THE CEMENT DID NOT SEEM RIGHT. HE USUALLY IMPLANTS THE EXETER STEM AT 5 MINS, HOWEVER, WAITED UNTIL 6 MINS BECAUSE THE CEMENT APPEARED AS IT WOULD AT 3 MINS. THE REMAINING CEMENT IN THE CEMENT GUN CHAMBER WAS THEN REMOVED TO ASSIST IN INDICATING SETTING TIME AT 9 MINUTES IT WAS STILL PLIABLE AND COULD EASILY BE PULLED APART. AT 17 MINS REMNANTS OF CEMENT FROM THE FEMORAL CANAL HAD GONE HARD, HOWEVER, THE REMAINING CEMENT FROM THE CEMENT GUN WENT HARD AT 19 MINS WHEN IT WENT HARD, IT USUALLY GETS SO HOT THAT YOU ARE UNABLE TO HOLD IT, HOWEVER THE CEMENT FROM THE GUN WAS ABLE TO BE HELD THROUGHOUT THE PROCESS."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SIMPLEX P - US TOBRA FD 10-PK IMPLANT LOD STRYKER ORTHOPAEDICS LIMERICK NA TDR023

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Other