BEUDAMED
    FDA Adverse Event Injury Summary report: N

    11.0MM TI HELICAL BLADE 105MM

    MDR report key: 3182210 · Received June 21, 2013

    Report

    Report Number
    3003506883-2013-00267
    Event Type
    Injury
    Date Received
    June 21, 2013
    Report Date
    May 24, 2013
    Manufacturer
    SYNTHES ELMIRA
    Product Code
    HSB
    PMA / PMN Number
    K011857
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS DEVICE WAS FOR TREATMENT NOT DIAGNOSIS. IMPLANT DATE REPORTED AS APPROX 6 WEEKS PRIOR TO (B)(6)2013. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. A REVIEW OF THE DEVICE HISTORY RECORDS WAS PERFORMED AND NO COMPLAINT RELATED ISSUES WERE FOUND. PLACEHOLDER.

    Description of Event or Problem · 1

    PATIENT EXPERIENCED PAIN DUE TO A MEDIAL PERFORATION OF THE FEMORAL HEAD STATUS POST TROCHANTERIC FIXATION NAIL, IMPLANT DATE UNKNOWN BUT REPORTED AS APPROXIMATELY SIX WEEKS PRIOR TO (B)(6) 2013. SUBSEQUENTLY, THE PATIENT RETURNED TO THE OR ON (B)(6) 2013, FOR TROCHANTERIC FIXATION NAIL HARDWARE REMOVAL AND REVISED TO TOTAL HIP REPLACEMENT. THIS REPORT IS FOR 11.0MM TI HELICAL BLADE 105MM. THIS IS 1 OF 3 REPORTS FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    282422 11.0MM TI HELICAL BLADE 105MM HSB SYNTHES ELMIRA 6983249

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Required Intervention