BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ECHELON PRIM FULLCOAT SZ 12 HO

    MDR report key: 3930228 · Received July 11, 2014

    Report

    Report Number
    1020279-2014-00409
    Event Type
    Injury
    Date Received
    July 11, 2014
    Date of Event
    July 8, 2014
    Report Date
    July 8, 2014
    Manufacturer
    SMITH & NEPHEW, INC.
    Product Code
    JDH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    .

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED DUE TO A BROKEN STEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    406482 ECHELON PRIM FULLCOAT SZ 12 HO HIP IMPLANT JDH SMITH & NEPHEW, INC. 09AM04893

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Required Intervention