BEUDAMED
    FDA Adverse Event Injury Summary report: N

    11MM/130 DEG TI CANN TROCH FIXATION NAIL 400MM/RIGHT-STER

    MDR report key: 4424094 · Received January 15, 2015

    Report

    Report Number
    1719045-2015-10043
    Event Type
    Injury
    Date Received
    January 15, 2015
    Report Date
    December 27, 2014
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    HSB
    PMA / PMN Number
    PK011857
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6). (B)(4). DATE OF ORIGINAL IMPLANT IS UNKNOWN. PER FACILITY, DEVICE WILL NOT BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN AS NO PRODUCT WAS RECEIVED. DEVICE HISTORY REVIEW: A REVIEW OF THE DEVICE HISTORY RECORD (S) FOR MANUFACTURING REVEALED NO COMPLAINT RELATED ISSUES FOR THIS COMPLAINT. LOT NUMBER: 6141382, MANUFACTURE DATE: MAY 20, 2009, EXPIRATION DATE: APRIL 1, 2018. DEVICE USED FOR TREATMENT, NOT DIAGNOSIS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD A TROCHANTERIC FIXATION NAIL (TFN) IMPLANTED ON AN UNKNOWN DATE. ON (B)(6) 2014, THE TFN, HELICAL BLADE, AND ONE 5.0MM LOCKING SCREW WERE REMOVED, DUE TO INFECTION, PAIN, IRRITATION AND DISCOMFORT. THE PATIENT WAS REVISED TO A GIRDLESTONE. NO ALLEGATIONS WERE REPORTED AGAINST THE REMOVED IMPLANTS AND THE EXPLANT SURGERY WAS COMPLETED SUCCESSFULLY. THE PATIENT¿S STATUS/OUTCOME WAS REPORTED AS ¿OKAY.¿ NO SURGICAL DELAY WAS REPORTED. THIS REPORT IS 1 OF 3 FOR COM-(B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    35079 11MM/130 DEG TI CANN TROCH FIXATION NAIL 400MM/RIGHT-STER ROD, FIXATION, INTRAMEDULLARY HSB SYNTHES MONUMENT 6141382

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention