BEUDAMED
    FDA Adverse Event Injury Summary report: N

    2520274-2013-02318

    MDR report key: 3091368 · Received May 3, 2013

    Report

    Report Number
    2520274-2013-02318
    Event Type
    Injury
    Date Received
    May 3, 2013
    Report Date
    April 5, 2013
    Manufacturer
    SYNTHES USA
    Product Code
    HSB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. WITHOUT A LOT NUMBER, THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. THE INVESTIGATION COULD NOT COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. PLACEHOLDER.

    Description of Event or Problem · 1

    A PATIENT WAS IMPLANTED WITH A TROCHANTERIC FIX NAIL (TFN) AND 11.0MM HELICAL BLADE ON (B)(6)2013. ON AN UNKNOWN DATE, THE TFN CUT OUT OF THE FEMORAL HEAD ANTERIORLY. PATIENT DEVELOPED A HIP INFECTION ON AN UNKNOWN DATE. THIS WAS VERIFIED BY THE SURGEON ON (B)(6) 2013. PATIENT UNDERWENT REVISION SURGERY FOR REMOVAL OF HARDWARE ON (B)(6) 2013 AND WAS CONVERTED TO HEMIARTHROPLASTY. THE TITANIUM TFN, 11.0MM TITANIUM HELICAL BLADE, AND 5.0MM TITANIUM LOCKING SCREW WERE EXPLANTED. NO ADDITIONAL INFORMATION IS AVAILABLE. THIS REPORT IS FOR AN UNKNOWN HELICAL BLADE. THIS IS REPORT 3 OF 3 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    194293 HSB SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Required Intervention