BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REFLECTION

    MDR report key: 1983715 · Received February 10, 2011

    Report

    Report Number
    1020279-2011-00035
    Event Type
    Injury
    Date Received
    February 10, 2011
    Date of Event
    January 6, 2011
    Report Date
    February 10, 2011
    Manufacturer
    SMITH & NEPHEW ORTHOPAEDICS, INC.
    Product Code
    JDH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    SURGERY TIME WAS EXTENDED DUE TO SEATING OF THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 REFLECTION CUP LINER JDH SMITH & NEPHEW ORTHOPAEDICS, INC. 71930640 04MM04750

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Hospitalization| R MODEL # 71333345, LOT 10JM10789, 10HM10906