BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BHR

    MDR report key: 2962935 · Received February 15, 2013

    Report

    Report Number
    3005477969-2013-00051
    Event Type
    Injury
    Date Received
    February 15, 2013
    Date of Event
    December 7, 2012
    Report Date
    April 15, 2013
    Manufacturer
    SMITH & NEPHEW ORTHOPAEDICS, LTD.
    Product Code
    NXT
    PMA / PMN Number
    P040033
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT REVISION SURGERY WAS PERFORMED DUE TO GROIN PAIN AND AVASCULAR NECROSIS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    66639 BHR ACETABULAR CUP NXT SMITH & NEPHEW ORTHOPAEDICS, LTD. 50676 056

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Hospitalization| R FEMORAL HEAD, PART# 74121142, PART# 51827