BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BHR

    MDR report key: 2040494 · Received April 6, 2011

    Report

    Report Number
    3005477969-2011-00081
    Event Type
    Injury
    Date Received
    April 6, 2011
    Date of Event
    April 1, 2011
    Report Date
    June 14, 2011
    Manufacturer
    SMITH & NEPHEW ORTHOPAEDICS, LTD.
    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 ON (B)(6) 2011 THAT REVISION SURGERY IS SCHEDULED ON (B)(6) 2011 AND PERFORMED DUE TO PAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BHR ACETABULAR CUP NXT SMITH & NEPHEW ORTHOPAEDICS, LTD. 58520 011

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Hospitalization| R MODULAR SLEEVE, PART#7422300, LOT# 111477| FEMORAL HEAD, PART#74222146, LOT# 10098