BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SM, LT ULNA COMPONENT

    MDR report key: 3202962 · Received July 2, 2013

    Report

    Report Number
    0002249697-2013-02206
    Event Type
    Injury
    Date Received
    July 2, 2013
    Date of Event
    June 19, 2013
    Report Date
    June 20, 2013
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    JDC
    PMA / PMN Number
    K980502
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AN EVENT REGARDING PERIPROSTHETIC FRACTURE INVOLVING SOLAR ULNA IMPLANT WAS REPORTED. THE EVENT WAS NOT CONFIRMED. METHOD AND RESULTS: DEVICE EVALUATION AND RESULTS: VISUAL, DIMENSIONAL AND FUNCTIONAL ANALYSIS COULD NOT BE PERFORMED AS THE DEVICE WAS NOT RETURNED. MEDICAL RECORDS RECEIVED AND EVALUATION: NOT PERFORMED AS INSUFFICIENT MEDICAL RECORDS WERE RECEIVED. DEVICE HISTORY REVIEW: THERE WERE NO REPORTED DISCREPANCIES. COMPLAINT HISTORY REVIEW: THERE HAVE BEEN NO OTHER EVENTS FOR THE REFERENCED LOT. CONCLUSIONS: THE EVENT WAS NOT CONFIRMED. THE EXACT CAUSE OF THE EVENT COULD NOT BE DETERMINED BECAUSE NO DEVICE WAS RETURNED FOR EVALUATION AND NO PATIENT MEDICAL RECORDS WERE PROVIDED FOR REVIEW. HOWEVER, IT WAS REPORTED THAT THE PERIPROSTHETIC FRACTURE WAS THE RESULT OF EXCESSIVE TRAUMA FROM A FALL. NO FURTHER INVESTIGATION FOR THIS EVENT IS POSSIBLE AT THIS TIME. IF DEVICES AND/OR ADDITIONAL INFORMATION BECOME AVAILABLE, THIS INVESTIGATION WILL BE REOPENED.

    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 AND IF IT BECOMES AVAILABLE, THE EVALUATION SUMMARY WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT. DEVICE PRODUCT NOT RETURNED TO MANUFACTURER.

    Description of Event or Problem · 1

    PT BROUGHT TO OR FOR REVISION OF LEFT ELBOW. STATUS POST FALL. LEFT ULNA FRACTURED BUT SOLAR TOTAL ELBOW COMPONENTS INTACT.

    Description of Event or Problem · 1

    PT BROUGHT TO OR FOR REVISION OF LEFT ELBOW. STATUS POST FALL. LEFT ULNA FRACTURED BUT SOLAR TOTAL ELBOW COMPONENTS INTACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    300911 SM, LT ULNA COMPONENT ELBOW JOINT METAL/POLYMER CONSTRAINED CEMENTED PROSTHESIS. JDC STRYKER ORTHOPAEDICS-MAHWAH MLK1HH

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Required Intervention