BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MOD CON DIST STEM 17 X 155 MM

    MDR report key: 2133721 · Received June 9, 2011

    Report

    Report Number
    9616680-2011-00377
    Event Type
    Injury
    Date Received
    June 9, 2011
    Date of Event
    May 18, 2011
    Report Date
    May 18, 2011
    Manufacturer
    STRYKER ORTHOPAEDICS CORK
    Product Code
    LZO
    PMA / PMN Number
    K013106
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AN EVAL OF THE DEVICE CANNOT BE PERFORMED AS THE DEVICE WAS NOT RETURNED TO THE MFR. ADD'L INFO WAS REQUESTED. IF IT BECOMES AVAILABLE, THE EVAL SUMMARY WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT. THIS IS THE SAME PT/EVENT AS MFR # 9616680-2011-00376.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT, "THE ORIGINAL MODULAR RESTORATION SUBSIDED. PLAN IS TO UP-SIZED MODULAR RESTORATION. WHEN SURGEON WAS TRYING TO SEPARATE THE PROXIMAL BODY AND DISTAL STEM, THE INSTRUMENT BROKE. IT NEVER SEPARATED THE TWO COMPONENTS. WE USED THE MCREYNOLDS ADAPTOR AND THE SLAP HAMMER AND PULLED THE STEM OUT WHOLE. X-RAYS ARE NOT INCLUDED. WE UP-SIZED THE MODULAR RESTORATION."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MOD CON DIST STEM 17 X 155 MM IMPLANT LZO STRYKER ORTHOPAEDICS CORK NA CAXK813A

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Required Intervention