BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NI

    MDR report key: 2121342 · Received June 6, 2011

    Report

    Report Number
    3003506883-2011-00030
    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

    ET.AL: NIRMAL C TEJWANI, MD. 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 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 FEBRUARY 2011 REPORTED : CASE# 1: PT PRESENTED WITH RIGHT PERIPROSTHETIC SUBTROCHANTERIC FEMUR FRACTURE FROM FALL ON STAIRS. PT UNDERWENT REMOVAL OF PRIOR HARDWARE FROM A HIP FUSION 25 YEARS AGO. A LAG SCREW AND A BROKEN SHAFT OF A SCREW WERE NOT REMOVED, PT REVISED TO LCP PROXIMAL FEMUR PLATE. POST OP X-RAYS TAKEN SHOWED GOOD PLACEMENT. PT RETURNED 2 WEEKS POST OP COMPLAINING OF INCREASED RIGHT THIGH PAIN. AN X-RAY SHOWED THE PLATE WAS BROKEN AT THE LEVEL OF THE PREVIOUS FRACTURE. LCP PLATE WAS REMOVED ALONG WITH PRIOR HARDWARE AND PT REVISED TO A CEPHALOMEDULLARY NAIL. PT'S FRACTURE HEALED. ONE 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 48 YR Required Intervention SCREW