BEUDAMED
    FDA Adverse Event Injury Summary report: N

    R3

    MDR report key: 2141868 · Received June 28, 2011

    Report

    Report Number
    1020279-2011-00224
    Event Type
    Injury
    Date Received
    June 28, 2011
    Date of Event
    June 8, 2011
    Report Date
    June 13, 2011
    Manufacturer
    SMITH AND NEPHEW, INC.
    Product Code
    LXH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHILE ENGAGING/DISENGAGING THE DEVICE INTRA-OPERATIVELY, THERE WAS A DELAY OF SURGERY TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 R3 ACETABULAR IMPACTOR LXH SMITH AND NEPHEW, INC. 11MB09251

    Patients

    Seq Age Sex Outcome Treatment
    1