BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    C-TAPER COCR LFIT HEAD 36MM/-2.5MM

    MDR report key: 2090565 · Received April 19, 2011

    Report

    Report Number
    2249697-2011-00531
    Event Type
    Malfunction
    Date Received
    April 19, 2011
    Date of Event
    March 29, 2011
    Report Date
    March 29, 2011
    Manufacturer
    STRYKER ORTHOPAEDICS MAHWAH
    Product Code
    JDI
    PMA / PMN Number
    K021310
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AN EVALUATION OF THE DEVICE CANNOT BE PERFORMED AS THE DEVICE WAS NOT RETURNED TO THE MANUFACTURER AT THIS TIME. IF ADDITIONAL INFO BECOMES AVAILABLE THEN IT WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT: "CIRCULATOR OPENED FEMORAL HEAD AND STATED THAT THE INNER PACKAGE LOOKED LIKE IT WAS ONCE WET. THE SURGEON LOOKED AT THE PACKAGE ALSO AND AGREED AND REFUSED TO USE THE PACKAGE DUE TO THE STERILITY IN QUESTION."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 C-TAPER COCR LFIT HEAD 36MM/-2.5MM IMPLANT JDI STRYKER ORTHOPAEDICS MAHWAH NA MJTDXL

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention