BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CENTPILLAR TMZF SIZE 4 LEFT

    MDR report key: 1874454 · Received October 12, 2010

    Report

    Report Number
    9616680-2010-00629
    Event Type
    Malfunction
    Date Received
    October 12, 2010
    Date of Event
    September 16, 2010
    Report Date
    September 21, 2010
    Manufacturer
    STRYKER ORTHOPAEDICS CORK
    Product Code
    MEH
    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

    AN EVALUATION OF THE DEVICE CANNOT BE PERFORMED AS THE DEVICE WAS NOT RETURNED TO THE MANUFACTURER. ADDITIONAL INFORMATION WAS REQUESTED. IF IT BECOMES AVAILABLE, THE EVALUATION SUMMARY WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT. THE SUBJECT DEVICE IS NOT CLEARED FOR SALE IN THE U.S., BUT A SIMILAR DEVICE IS COMMERCIALLY AVAILABLE IN THE U.S.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT, "THE SURGEON NOTICED A CRACK ON THE MEDIAL SLIT OF THE CENTPILLAR ON AN X-RAY. A PROXIMAL FIXATION OF THE STEM IS EXCELLENT. AN ALIGNMENT IS A LITTLE VALGUS."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CENTPILLAR TMZF SIZE 4 LEFT IMPLANT MEH STRYKER ORTHOPAEDICS CORK NA 22836501

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Other