BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SIMPLEX P-JAPANESE TWIN PACK

    MDR report key: 2162193 · Received July 7, 2011

    Report

    Report Number
    9610726-2011-00241
    Event Type
    Injury
    Date Received
    July 7, 2011
    Date of Event
    June 16, 2011
    Report Date
    June 16, 2011
    Manufacturer
    STRYKER ORTHOPAEDICS LIMERICK
    Product Code
    LOD
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE SUBJECT DEVICE IS NOT CLEARED FOR SALE IN THE U.S., BUT A SIMILAR DEVICE IS COMMERCIALLY AVAILABLE IN THE U.S. WHEN COMPLETED, THE EVALUATION SUMMARY WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CEMENT HARDENED QUICKLY. THE SURGEON MIXED THE 2 PACS OF THE CEMENT WITH ACM FOR 1 MIN AND 30 SEC. THE CEMENT HAD BEEN SET TO THE CEMENT GUN (ELAPSED TIME: 2 MIN AND 30 SEC TO 3 MIN FROM STARTING TO MIX THE CEMENT) AFTER SETTING TO THE CEMENT GUN, THE SURGEON INSERTED THE CEMENT TO THE CANAL WITH PRESSURIZER AND STEM (B)(4) WAS INSERTED (ELAPSED TIME: 4 MIN FROM STARTING TO MIX THE CEMENT) BUT, THE STEM COULD NOT BE INSERTED PROPERLY BECAUSE THE CEMENT HAD ALREADY HARDENED QUICKLY. SO, THE CEMENT IN THE CANAL WAS REMOVED. DURING REMOVING THE CEMENT, THE BLOOD PRESSURE SLIGHTLY FELL BUT RECOVERED SOON. THE SPARE CEMENT (SAME LOT NUMBER) WAS USED IN SIMILAR SITUATION AND IT HARDENED PROPERLY. ON THE OTHER HAND, THE REMAINDER OF THE CEMENT WHICH QUICKLY HARDENED AND DID NOT INSERT INTO THE CANAL HAD BEEN HOT FOR 6 MIN FROM STARTING TO MIX IT AND HARDENED FOR 7 MIN FROM STARTING TO MIX IT. THE CEMENT AND ACM ARE STORED IN 24.5C TEMP USING BEFORE 24 HOURS AND BEING STARTED TO USE. SPARE PRODUCTS OF THESE PRODUCTS WERE USUALLY STORED IN THE HOSPITAL. THE TEMP OF THE OPERATION ROOM WAS 24.5 C. THE PROCEDURE TYPE WAS BHA THE TEXTURE OF THE CEMENT WAS PROPERLY (NOT POWDERED AND NOT RUNNY). ALL THE MONOMER AND POLYMER WAS USED. THE SECOND EVENT IS IMPROPER STERILIZATION. THE STERILIZATION SEAL SHOWS YELLOW. THE SURGEON NEEDS THE STERILIZATION CONFIRMATION OF THE CEMENT AND HEALTH HAZARD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SIMPLEX P-JAPANESE TWIN PACK IMPLANT LOD STRYKER ORTHOPAEDICS LIMERICK NA JJR039

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Other