BEUDAMED
    FDA Adverse Event Other Summary report: N

    ENCORE KNEE

    MDR report key: 1943576 · Received December 6, 2010

    Report

    Report Number
    1644408-2010-00643
    Event Type
    Other
    Date Received
    December 6, 2010
    Date of Event
    August 26, 2010
    Report Date
    November 19, 2010
    Product Code
    JWH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    REVISION SURGERY - THE SURGEON REPLACED THE ETK KNEE PROSTHESIS WITH AN ENCORE ULTRA-CONGRUENT TIBIAL INSERT DUE TO PE-GRANULOMA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENCORE KNEE ULTRA CONGRUENT INSERT JWH 509161

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention (B)(4), LOT 752871