BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RICHARDS RECON PROXIMAL SCREW

    MDR report key: 2110472 · Received May 25, 2011

    Report

    Report Number
    2110472
    Event Type
    Injury
    Date Received
    May 25, 2011
    Date of Event
    May 9, 2011
    Report Date
    May 25, 2011
    Manufacturer
    SMITH AND NEPHEW
    Product Code
    HWC
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    VA, US

    Narratives

    Description of Event or Problem · 1

    PATIENT UNDERWENT IMPLANTATION OF RICHARDS RECON NAIL WITH RECON PROXIMAL SCREW SEVERAL YEARS AGO FOR BONE LESION. PATIENT RETURNED TO OR WITH DEGENERATIVE JOINT DISEASE AND PAINFUL HARDWARE OF THE HIP RECENTLY. IT WAS NOTED THAT THE PROXIMAL SCREW WAS BROKEN (LATERAL PART OF THE BROKEN BOLT WAS PULLED OUT AND THE NAIL WAS REMOVED). IT WAS CLEARLY IMPINGING ON THE ABDUCTOR MECHANISM AND ILIUM AND CAUSING A BURSITIS REACTION. A BIPOLAR HIP REPAIR WAS THEN PERFORMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RICHARDS RECON PROXIMAL SCREW SCREW, FIXATION, BONE HWC SMITH AND NEPHEW 122246 3A38355

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Hospitalization| R