BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GENESIS I

    MDR report key: 2181636 · Received July 27, 2011

    Report

    Report Number
    1020279-2011-00281
    Event Type
    Injury
    Date Received
    July 27, 2011
    Date of Event
    June 21, 2011
    Report Date
    July 27, 2011
    Manufacturer
    SMITH & NEPHEW, INC. ORTHOPAEDIC DIVISION
    Product Code
    JWH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    MEDWATCH REPORT # FILED BY THE RISK MANAGER IS (B)(4).

    Description of Event or Problem · 1

    IT HAS BEEN REPORTED THAT A REVISION SURGERY WAS PERFORMED DUE TO WEAR OF THE POLY. THE PRIMARY SURGERY OCCURRED APPROXIMATELY 20 YEARS AGO. THE TYPE OF POLY BEING REVISED WAS A GEN I 10 MM INSERT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GENESIS I INSERT JWH SMITH & NEPHEW, INC. ORTHOPAEDIC DIVISION

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Hospitalization| R