BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ECHELON

    MDR report key: 2111152 · Received June 2, 2011

    Report

    Report Number
    1020279-2011-00186
    Event Type
    Injury
    Date Received
    June 2, 2011
    Date of Event
    May 30, 2011
    Report Date
    June 2, 2011
    Manufacturer
    SMITH AND NEPHEW, INC.
    Product Code
    LPH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SMITH & NEPHEW, INC. IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISIONS. THIS REPORT MAY BE BASED UPON INFORMATION WHICH SMITH & NEPHEW, INC. HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY FDA, SMITH & NEPHEW, INC., OR ITS EMPLOYEES, THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, SMITH & NEPHEW, INC., OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED DUE TO FRACTURE OF THE STEM. IT IS NOTED BY THE SURGEON THE STEM USED WAS NOT IDEAL SIZE FOR LARGER ACTIVE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ECHELON FEMORAL HIP STEM LPH SMITH AND NEPHEW, INC. 07HM14115A

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Congenital Anomaly| H