BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GENESIS II

    MDR report key: 2052319 · Received April 12, 2011

    Report

    Report Number
    1020279-2011-00122
    Event Type
    Injury
    Date Received
    April 12, 2011
    Date of Event
    October 23, 2009
    Report Date
    April 12, 2011
    Manufacturer
    SMITH & NEPHEW, INC. ORTHOPAEDIC DIVISION
    Product Code
    JWH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT HAS BEEN REPORTED THAT A REVISION SURGERY WAS PERFORMED DUE TO MISALIGNMENT. THE PRODUCT WILL NOT BE RETURNED AS IT WAS DISPOSED OF AFTER THE SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GENESIS II TIBIA BASE JWH SMITH & NEPHEW, INC. ORTHOPAEDIC DIVISION 04EM00371

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R PART # 71421014, LOT # 04AM05584| PART # 71420574, LOT # 02DM06422| PART # 71420816, LOT # 04EM10393