BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN_KIE_PRODUCT

    MDR report key: 4100454 · Received September 19, 2014

    Report

    Report Number
    0009610622-2014-00481
    Event Type
    Injury
    Date Received
    September 19, 2014
    Date of Event
    August 25, 2014
    Report Date
    August 25, 2014
    Manufacturer
    STRYKER TRAUMA KIEL
    Product Code
    HSB
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE REVIEW OF MANUFACTURING DOCUMENTS COULD NOT BE CARRIED OUT AS NO LOT-NO WAS GIVEN. AS NO ITEM WAS RETURNED NO PHYSICAL EXAMINATION COULD BE CARRIED OUT. IN THIS CASE, REFERRING TO RECEIVED INFORMATION, THE NAIL BROKE AFTER AN UNKNOWN PERIOD OF IMPLANTATION. THUS, AS WORST CASE, IT COULD NOT BE EXCLUDED THAT THE NAIL HAD BEEN IMPLANTED LESS THAN 6 MONTHS. IMPLANT BREAKAGE MAY OCCUR WHEN THE MATERIAL IS SUBJECTED TO REPEATED LOADING AND UNLOADING RESULTING FATIGUE OF MATERIAL. IF THE LOADS ARE ABOVE A CERTAIN THRESHOLD (MICROSCOPIC) CRACKS WILL BEGIN TO FORM ON THE SURFACE. WITH AVAILABLE INFORMATION A DEFICIENCY OF THE NAIL COULD NOT BE VERIFIED. DEVICE WAS NOT AVAILABLE.

    Additional Manufacturer Narrative · 1

    ONCE THE INVESTIGATION HAS BEEN COMPLETED ANY ADDITIONAL INFORMATION WILL BE REPORTED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT HAD LEFT HIP REVISION DUE TO BROKEN GAMMA NAIL. SURGEON TOOK OUT BROKEN GAMMA NAIL AND CONVERTED TO A TOTAL HIP.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT HAD LEFT HIP REVISION DUE TO BROKEN GAMMA NAIL. SURGEON TOOK OUT BROKEN GAMMA NAIL AND CONVERTED TO A TOTAL HIP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    585182 UNKNOWN_KIE_PRODUCT IMPLANT HSB STRYKER TRAUMA KIEL UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Required Intervention