BEUDAMED
    FDA Adverse Event Summary report: N

    SIMPLEX P - CE FULL DOSE 10-PK

    MDR report key: 1053580 · Received May 27, 2008

    Report

    Report Number
    9610726-2008-00020
    Date Received
    May 27, 2008
    Date of Event
    March 28, 2008
    Report Date
    April 1, 2008
    Manufacturer
    STRYKER ORTHOPAEDICS LIMERICK
    Product Code
    LOD
    PMA / PMN Number
    N17004
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CEMENT WAS MIXED AS PER INSTRUCTIONS FOR USE IN A TRH PROCEDURE. THE CUSTOMER FURTHER REPORTED THAT APPROX 3/4 WAS USED AND A STEM WAS IMPLANTED. THE CUSTOMER REPORTS THAT THEATRES STAFF NOTICED BUBBLES AND CLUMPS WERE PRESENT IN THE REMAINING MIXTURE NOT IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SIMPLEX P - CE FULL DOSE 10-PK IMPLANT LOD STRYKER ORTHOPAEDICS LIMERICK NA CIO148

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other