BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GENESIS II

    MDR report key: 2022350 · Received March 17, 2011

    Report

    Report Number
    8010764-2011-00012
    Event Type
    Injury
    Date Received
    March 17, 2011
    Date of Event
    January 25, 2011
    Report Date
    March 17, 2011
    Manufacturer
    SMITH & NEPHEW, INC. ORTHOPAEDIC DIVISION-GERMANY
    Product Code
    JWH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT HAS BEEN REPORTED THAT REVISION SURGERY WAS PERFORMED DUE TO DISASSOCIATION OF THE INSERT. IT WAS REPORTED THAT THE PATIENT REPEATEDLY SITS ON THE FLOOR JAPANESE STYLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GENESIS II INSERT JWH SMITH & NEPHEW, INC. ORTHOPAEDIC DIVISION-GERMANY 09BT28265

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R PART # 71420180, LOT # 10BT399954| PART # 71421113, LOT # UNK