BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PUNCH THRU TIBIAL BASE PLATE

    MDR report key: 1233921 · Received November 14, 2008

    Report

    Report Number
    2249697-2008-00361
    Event Type
    Injury
    Date Received
    November 14, 2008
    Date of Event
    October 20, 2008
    Report Date
    October 20, 2008
    Manufacturer
    STRYKER ORTHOPAEDICS MAHWAH
    Product Code
    LXH
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE IS NOT AVAILABLE FOR EVALUATION. NO EVALUATION WILL BE PERFORMED. ADDITIONAL INFO HAS BEEN REQUESTED AND IF RECEIVED WILL BE PROVIDED ON A SUPPLEMENTAL REPORT. DEVICE EVALUATION ANTICIPATED, BUT NOT YET BEGUN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT, "AFTER THE TKA SURGERY IN THE OPERATION ROOM, THE SURGEON FOUND A FOREIGN MATERIAL ON THE X-RAY. THE SURGEON IMMEDIATELY PERFORMED A SURGERY TO REMOVE THE FOREIGN MATERIAL FROM THE PATIENT. AFTER THE SURGERY, THE SURGEON AND OUR SR FOUND THE BROKEN TIBIAL BASE PLATE TRIAL (FRACTURED THE PROJECTED PART)."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PUNCH THRU TIBIAL BASE PLATE INSTRUMENT LXH STRYKER ORTHOPAEDICS MAHWAH NA CSW21

    Patients

    Seq Age Sex Outcome Treatment
    1 NI Required Intervention