BEUDAMED
    FDA Adverse Event Injury Summary report: N

    R3

    MDR report key: 2221221 · Received August 24, 2011

    Report

    Report Number
    3005477969-2011-00196
    Event Type
    Injury
    Date Received
    August 24, 2011
    Date of Event
    August 13, 2011
    Report Date
    February 2, 2012
    Manufacturer
    WARWICK UK MANUFACTURING SITE
    Product Code
    NXT
    PMA / PMN Number
    P040033
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT REVISION SURGERY WAS PERFORMED DUE TO DISASSOCIATION.

    Description of Event or Problem · 1

    REVISION SURGERY WAS PERFORMED DUE TO INFECTION AND DISASSOCIATION OF THE ACETABULAR LINER AND SCREWS FROM THE ACETABULAR SHELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 R3 R3 CO-CR LINER NXT WARWICK UK MANUFACTURING SITE 08GW17906

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Hospitalization| R LINER SHELL, PART # 71331958, LOT # 07KM212504| CORIN MINI STEM, PART # UNKNOWN, LOT # UNKNOWN| MODULAR HEAD, PART # 74222146, LOT # 08MW20356