BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NI

    MDR report key: 2121336 · Received June 6, 2011

    Report

    Report Number
    3003506883-2011-00033
    Event Type
    Injury
    Date Received
    June 6, 2011
    Report Date
    November 14, 2025
    Manufacturer
    SYNTHES ELMIRA
    Product Code
    HRS
    PMA / PMN Number
    K030858
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER
    Health Professional
    Yes

    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)(4) 2011 REPORTED: CASE #4: PT PRESENTED WITH TWO YEAR OLD RIGHT PERTROCHANTERIC NONUNION AFTER GUNSHOT WOUND. PT HAD A UNK PRIOR IMPLANTATION AND REMOVAL AND AN ASEPTIC NONUNION TREATED WITH BLADE PLATE. WHICH FAILED TWO MONTHS POST OP. HARDWARE WAS REMOVED PT REVISED TO LCP PROXIMAL FEMUR PLATE. TWO WEEKS POST OP PT'S PAIN INCREASED, AN X-RAY SHOWED PLATE BROKEN AT THE SCREW PLATE INTERFACE PROXIMATELY. PT QUIT SMOKING AND PT WAS REVISED TO CEPHALOMEDULLARY NAIL AND IN TEN MONTHS THE NONUNION HEALED. FOUR 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 36 YR Unknown Required Intervention SCREW