BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BHR

    MDR report key: 3022030 · Received March 26, 2013

    Report

    Report Number
    1020279-2013-00180
    Event Type
    Injury
    Date Received
    March 26, 2013
    Date of Event
    October 23, 2008
    Report Date
    August 2, 2013
    Manufacturer
    SMITH & NEPHEW ORTHOPAEDICS, LTD.
    Product Code
    NXT
    PMA / PMN Number
    P040033
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INITIAL INFORMATION SUPPLIED BY THE REPORTER OF THIS INCIDENT INDICATED THE DEVICE MANUFACTURING SITE WAS SMITH & NEPHEW, INC., (B)(4), USA AS IDENTIFIED IN THIS REPORT NUMBER. NEW INFORMATION HAS SINCE BEEN SUPPLIED WHICH INDICATES THE MANUFACTURING SITE FOR THE KNOWN DEVICES IN THIS CASE ARE SMITH & NEPHEW ORTHOPAEDICS, LTD., (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED DUE TO PAIN AND DISCOMFORT.

    Description of Event or Problem · 1

    REVISION SURGERY WAS PERFORMED DUE TO ASEPTIC FEMORAL LOOSENING AND GROIN PAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    123094 BHR ACETABULAR CUP NXT SMITH & NEPHEW ORTHOPAEDICS, LTD. 089966

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Hospitalization| R 71303200 -COCR 12/14 FEM HD 32 + 0 -LOT: ASKU| FEMORAL HEAD, PART# 74121146, LOT# 83168