BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALUMINA

    MDR report key: 1983135 · Received February 10, 2011

    Report

    Report Number
    1020279-2011-00033
    Event Type
    Injury
    Date Received
    February 10, 2011
    Date of Event
    December 14, 2010
    Report Date
    February 10, 2011
    Manufacturer
    SMITH & NEPHEW, ORTHOPEDICS
    Product Code
    LPF
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT SURGERY WAS DELAYED DUE TO A FRACTURE OF THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ALUMINA CERAMIC LINER LPF SMITH & NEPHEW, ORTHOPEDICS 09JM13594

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention