BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SIMPLEX P - CE TOBRA FD 10-PK

    MDR report key: 1588332 · Received January 14, 2010

    Report

    Report Number
    9610726-2010-00013
    Event Type
    Malfunction
    Date Received
    January 14, 2010
    Date of Event
    December 22, 2009
    Report Date
    December 22, 2009
    Manufacturer
    STRYKER ORTHOPAEDICS LIMERICK
    Product Code
    LOD
    PMA / PMN Number
    K014199
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    AN EVALUATION OF THE DEVICE CANNOT BE PERFORMED AS THE DEVICE WAS NOT RETURNED TO THE MFR. IF ADDITIONAL INFO BECOMES AVAILABLE, IT WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT. CATALOG NUMBERS AND LOT CODES OF OTHER DEVICES LISTED IN THIS REPORT: CAT # 6197-1-010, LOT # THQ50, DESCRIPTION: SIMPLEX P - CE TOBRA FD 10-PK; CAT # 6197-1-010, LOT # THQ51, DESCRIPTION: SIMPLEX P - CE TOBRA FD 10-PK.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE NURSE REPORTED TO THE PRODUCT MGR THAT THEY ESTABLISHED UNSTABLE CURING TIMES FOR SIMPLEX TOBRA BONE CEMENT. THE NURSE FURTHER REPORTED THAT THIS ONLY OCCURS WITH THE FULL DOSE PACKAGES NOT WITH HALF DOSES. AT THE MOMENT THEY CEMENT A KNEE IN TWO STAGES WHERE THEY DID IT IN ONCE IN THE PAST. BOTH HALF DOSE AND FULL DOSE PACKAGES ARE STORED IN THE SAME ROOM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SIMPLEX P - CE TOBRA FD 10-PK IMPLANT LOD STRYKER ORTHOPAEDICS LIMERICK NA THQ047

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other