BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NI

    MDR report key: 2061247 · Received April 11, 2011

    Report

    Report Number
    2520274-2011-00089
    Event Type
    Injury
    Date Received
    April 11, 2011
    Report Date
    March 25, 2011
    Manufacturer
    SYNTHES (USA)
    Product Code
    HSB
    PMA / PMN Number
    NI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION HAS BEEN REQUESTED. SYNTHES IS UNABLE TO DETERMINE MANUFACTURING SITE OR MANUFACTURING DATE WITHOUT A PART NUMBER OR A LOT NUMBER. SYNTHES IS UNABLE TO DETERMINE 510 (K) # WITHOUT A PART NUMBER OR LOT NUMBER. INVESTIGATION IS ONGOING; NO CONCLUSION COULD BE DRAWN AS NO DEVICE WAS RETURNED OR LOT NUMBER PROVIDED.

    Description of Event or Problem · 1

    A PATIENT WITH OSTEOPOROSIS AND 2 TOTAL HIP REPLACEMENTS FELL AND SUFFERED A SPINAL FEMORAL FRACTURE. A NAIL WAS IMPLANTED IN (B)(6) 2008 AND PATIENT WENT BACK TO BEING ACTIVE IN 2008 AND 2009. PATIENT BEGAN COMPLAINING OF KNEE DISCOMFORT IN 2010. THE SCREWS ABOVE THE KNEE WERE REMOVED IN (B)(6) 2010 AND IN (B)(6) THE PATIENT CONTINUED TO COMPLAIN OF PAIN. SHE HAD THE KNEE SCOPED AND INJECTIONS AND WAS PLANNING ON A TOTAL KNEE REPLACEMENT BUT IN (B)(6) 2011 THE NAIL BROKE. BROKEN NAIL WAS REMOVED ON AN UNKNOWN DATE AND PATIENT WAS REVISED TO ANOTHER NAIL, A PLATE AND ALLOGRAFT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NI NAIL HSB SYNTHES (USA) NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Required Intervention SCREWS