BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NI

    MDR report key: 1984563 · Received February 2, 2011

    Report

    Report Number
    2520274-2011-00020
    Event Type
    Injury
    Date Received
    February 2, 2011
    Report Date
    January 11, 2011
    Manufacturer
    SYNTHES (USA)
    Product Code
    HWC
    PMA / PMN Number
    NI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    JOURNAL ARTICLE "NEW TECHNIQUE FOR REVISING DYNAMIC HIP SCREW FIXATIONS WITH LAG SCREW IN SITU": ORTHOP TRAUMA. VOLUME 24, NOVEMBER 10, OCTOBER 2010. SAMIER GOYAL, MRCS, NICHOLAS J.K. MILLER, MRCS, AND SATYAJIT SINHA, FRCS. SYNTHES IS UNABLE TO PROVIDE THE MFR, THE PMA/510K NUMBER AND THE DATE OF MANUFACTURE AS NO PRODUCT WAS REC'D 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.

    Description of Event or Problem · 1

    A JOURNAL ARTICLE "NEW TECHNIQUE FOR REVISING DYNAMIC HIP SCREW FIXATIONS WITH LAG SCREW IN SITU" FROM ORTHOP TRAUMA. VOLUME 24 NOVEMBER 10, OCTOBER 2010 REPORTED: A TOTAL OF EIGHT CASES WERE REVISED FROM DYNAMIC HIP SCREW FIXATION TO TOTAL HIP ARTHROPLASTY. IN FIVE (5) CASES THE LAG SCREW HAS PARTIALLY CUT OUT LEADING TO MECHANICAL EROSION OF THE ACETABULUM. THE REMAINING THREE (3) CASES THE PTS EXPERIENCED GROIN PAIN SECONDARY TO DEGENERATIVE CHANGES DEVELOPING IN THE HIP. IN ALL CASES PTS WERE REVISED EXCISING THE FEMORAL HEAD WITH THE LAG SCREW IN SITU REDUCING THE RISK OF IATROGENIC FRACTURES. THIS IS TWO OF THREE REPORTS FOR THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NI DHS/DCS LAG SCREWS HWC SYNTHES (USA) NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 NI Required Intervention