BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NI

    MDR report key: 2121333 · Received June 6, 2011

    Report

    Report Number
    3003506883-2011-00032
    Event Type
    Injury
    Date Received
    June 6, 2011
    Report Date
    May 31, 2011
    Manufacturer
    SYNTHES ELMIRA
    Product Code
    HRS
    PMA / PMN Number
    K030858
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): UNABLE TO PROVIDE THE DATE OF MANUFACTURE AS NO PRODUCT WAS RETURNED AND NO PART/LOT NUMBER WAS PROVIDED. THE INVESTIGATION COULD NOT BE COMPLETED, NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RETURNED AND NO PART/LOT NUMBER WAS PROVIDED. WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE REQUESTED.

    Description of Event or Problem · 1

    A JOURNAL ARTICLE: FAILURE OF PROXIMAL FEMORAL LOCKING COMPRESSION PLATE: A CASE SERIES: ORTHOP TRAUMA. VOLUME 25, NUMBER 2 (B)(6) 2011 REPORTED: CASE #3: PT WITH NONUNION HISTORY OF LEFT FEMUR SUBTROCHANTERIC FRACTURE WITH TWO PREVIOUS SURGERIES WITH INTRAMEDULLARY NAIL AND BLADE PLATE WITH FRACTURES OF HARDWARE BOTH TIMES UNDERWENT REPAIR OF NONUNION WITH LCP PROXIMAL FEMUR PLATE. PT PLACED ON ANTIBIOTICS AND HAD CULTURES TAKEN. PT EXPERIENCED MILD PAIN: AT SIX MONTHS PT EXPERIENCED ACUTE ONSET OF LEFT THIGH PAIN AND WAS NOTED TO HAVE A NONUNION. HARDWARE WAS REMOVED PT REVISED TO BLADE PLATE WITH VALGUS OSTEOTOMY AND WENT ONTO A UNION. THREE OF SIX REPORTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NI LCP PROXIMAL FEMUR PLATE HRS SYNTHES ELMIRA NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Required Intervention SCREW