BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRIMARY SUPER SECUR-FIT PLUS SIZE 7-11MM DISTAL S

    MDR report key: 2012950 · Received March 2, 2011

    Report

    Report Number
    9616680-2011-00090
    Event Type
    Injury
    Date Received
    March 2, 2011
    Date of Event
    January 1, 2011
    Report Date
    February 14, 2011
    Manufacturer
    STRYKER ORTHOPAEDICS CORK
    Product Code
    MEH
    PMA / PMN Number
    K020615
    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

    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.

    Description of Event or Problem · 1

    AT THE REGULAR OUTPATIENT, IT WAS FOUND THE BREAKAGE OF THE SLIT OF THE END OF THE STEM ON THE X RAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PRIMARY SUPER SECUR-FIT PLUS SIZE 7-11MM DISTAL S IMPLANT MEH STRYKER ORTHOPAEDICS CORK NA 25297901

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other