BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRIATHLON PRIM TIB BASEPLATE - CEMENTED

    MDR report key: 1250779 · Received December 1, 2008

    Report

    Report Number
    9610726-2008-00102
    Event Type
    Malfunction
    Date Received
    December 1, 2008
    Date of Event
    November 4, 2008
    Report Date
    November 11, 2008
    Manufacturer
    STRYKER ORTHOPAEDICS LIMERICK
    Product Code
    HSH
    PMA / PMN Number
    K031729
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    OUR CUSTOMER HAS REPORTED US VIA DISTRIBUTOR THAT DURING A SURGERY, IT HAS BEEN DETECTED BY THE SURGEON THAT THE PACKAGE OF THE REFERENCE 5520-B-400 CONTAINS THE REFERENCE 5520-B-200.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRIATHLON PRIM TIB BASEPLATE - CEMENTED IMPLANT HSH STRYKER ORTHOPAEDICS LIMERICK NA SH8NT

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other