BEUDAMED
    FDA Adverse Event Injury Summary report: N

    KNEE IMPLANT

    MDR report key: 2162594 · Received July 14, 2011

    Report

    Report Number
    1020279-2011-00255
    Event Type
    Injury
    Date Received
    July 14, 2011
    Date of Event
    June 16, 2011
    Report Date
    July 12, 2011
    Manufacturer
    SMITH & NEPHEW, INC. ORTHOPAEDIC DIVISION
    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 A REVISION SURGERY WAS PERFORMED DUE TO LIGAMENT LAXITY. PRODUCT WILL NOT BE RETURNED FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 KNEE IMPLANT FEMORAL JWH SMITH & NEPHEW, INC. ORTHOPAEDIC DIVISION

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R