BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SIMPLEX P - CE FULL DOSE 10-PK

    MDR report key: 2935704 · Received January 3, 2013

    Report

    Report Number
    9610726-2013-90001
    Event Type
    Malfunction
    Date Received
    January 3, 2013
    Date of Event
    December 12, 2012
    Report Date
    December 12, 2012
    Manufacturer
    STRYKER ORTHOPAEDICS LIMERICK
    Product Code
    LOD
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RO
    Reporter Occupation
    PHYSICIAN

    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

    THE SURGEON REPORTED TO SALES REP THAT HE USED 4 CEMENT DOSES BEFORE FINISHING THE SURGERY. THREE OUT OF FOUR DOSES FROM SAME BOX (SAME LOT) COULDN'T BE USED BECAUSE THE CEMENT DIDN'T BECOME HARD AND THE CUP WAS NOT FIRMLY FIXED IN POSITION. THE SURGERY WAS COMPLETED USING THE FOURTH CEMENT DOSE FROM ANOTHER BOX (DIFFERENT LOT). IT WAS FURTHER REPORTED THAT THERE WAS A MINIMAL DELAY IN THE SURGICAL PROCEDURE AND NO MEDICAL INTERVENTION REQUIRED IN ADDITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    3995 SIMPLEX P - CE FULL DOSE 10-PK IMPLANT LOD STRYKER ORTHOPAEDICS LIMERICK NA CFT080

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other