BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SIMPLEX P-JAPANESE TWIN PACK

    MDR report key: 2001676 · Received February 22, 2011

    Report

    Report Number
    9610726-2011-00046
    Event Type
    Injury
    Date Received
    February 22, 2011
    Date of Event
    February 4, 2011
    Report Date
    February 7, 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

    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. THE SUBJECT DEVICE IS NOT CLEARED FOR SALE IN THE U.S., BUT A SIMILAR DEVICE IS COMMERCIALLY AVAILABLE IN THE U.S.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CEMENT WAS USED WITH AN ACM AND CEMENT GUN. IT WAS INSERTED INTO THE FEMORAL CANAL 7 MINUTES LATER FROM THE BEGINNING OF MIXING. AFTER HEAD NECK STEM WAS IMPLANTED, THE PATIENT'S HEART STOPPED DURING WAITING FOR HARDENING OF THE CEMENT. SO, THE SURGEON STOPPED OPERATION ONCE, AND PROVIDED CARDIOPULMONARY RESUSCITATION. THE SURGEON WERE ABLE TO REVIVE THE PATIENT. PRESSURIZER WAS NOT USED. THE CANAL WAS WASHED BY A SYRINGE. THE INTRAMEDULLARY PLUG WAS NOT USED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Other