BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SIMPLEX P FULL DOSE 1 PACK

    MDR report key: 1960196 · Received December 21, 2010

    Report

    Report Number
    9610726-2010-00482
    Event Type
    Malfunction
    Date Received
    December 21, 2010
    Date of Event
    December 9, 2010
    Report Date
    December 9, 2010
    Manufacturer
    STRYKER ORTHOPAEDICS LIMERICK
    Product Code
    LOD
    PMA / PMN Number
    N17004
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RI, US
    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. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, IT WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    THE COORDINATOR REPORTED THAT WHEN THEY OPENED ONE OF THE MONOMERS, THE LIQUID PORTION TO MIX THE CEMENT, THEY NOTICED THAT IT WASN'T SEALED CORRECTLY, THE PAPER WAS LIFTED OFF THE PLASTIC. THEY NOTIFIED THE OTHER 2 JOINT ROOMS TO SEE IF THEY HAD THE SAME LOT NUMBER AND REALIZED THEY DID AND REALIZED THAT A COUPLE OF THEIR MONOMERS WOULD NOT SEAL AS WELL. IN ONE CASE IT LOOKED LIKE THE PLASTIC PORTION OF THE MONOMER WAS MELTED. REP IS LOOKING THROUGH ALL THE OTHER PACKAGES IN THE STORAGE ROOM TO SEE IF THE OTHER CEMENT PACKAGES HAVE PROBLEMS WITH THE PACKAGING THAT HAVE THE SAME LOT NUMBER. BECAUSE OF THE QUESTION OF STERILITY OF THE PACKAGING THE ROOMS HAD TO BE BROKEN DOWN, INSTRUMENTS RESTERILIZED AND SUPPLIES TO BE REPICKED CAUSING THE PATIENT TO BE UNDER ANESTHESIA HALF AN HOUR TO 1 HOUR UNTIL THE CASE IS SET UP AGAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SIMPLEX P FULL DOSE 1 PACK IMPLANT LOD STRYKER ORTHOPAEDICS LIMERICK NA RJP201

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR Other