BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SIMPLEX P-JAPANESE TWIN PACK

    MDR report key: 1635624 · Received March 10, 2010

    Report

    Report Number
    9610726-2010-00082
    Event Type
    Malfunction
    Date Received
    March 10, 2010
    Date of Event
    March 1, 2010
    Report Date
    March 1, 2010
    Manufacturer
    STRYKER ORTHOPAEDICS LIMERICK
    Product Code
    LOD
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION. THE SUBJECT DEVICE IS NOT CLEARED FOR SALE IN THE U.S., BUT A SIMILAR DEVICE IS COMMERCIALLY AVAILABLE IN THE U.S AND WAS CLEARED UNDER N17004.

    Description of Event or Problem · 1

    DURING SURGERY, A FOREIGN MATERIAL WAS FOUND IN THE CEMENT WHEN MIXING. ANOTHER SIMPLEX P WAS USED WITHOUT PROBLEM. THERE WAS NO ADVERSE OUTCOME TO THE PATIENT DUE TO THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SIMPLEX P-JAPANESE TWIN PACK IMPLANT LOD STRYKER ORTHOPAEDICS LIMERICK UNK JIQ030

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other