BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BHR

    MDR report key: 3070287 · Received April 22, 2013

    Report

    Report Number
    3005477969-2013-00153
    Event Type
    Injury
    Date Received
    April 22, 2013
    Date of Event
    November 3, 2012
    Report Date
    April 10, 2014
    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 THAT REVISION SURGERY WAS PERFORMED. THE DEVICES WERE IMPLANTED IN (B)(6) 2009. POST OPERATIVE X-RAY SHOWED STEEP INCLINATION OF THE ACETABULAR CUP (OVER 60 DEGREES). IN THE (B)(6) OF 2012, THE PATIENT SUFFERED A PERMANENT LOUD SQUEAKING NOISE, PRESSURE AND A SLIGHT ACHE IN THE LEFT GROIN. ON (B)(6) 2012, THE SURGEON NOTED NORMAL MOVEMENT OF THE HIP AND NO RADIOLOGICAL SIGNS OF LOOSENING. INCREASED METAL ION BLOOD LEVELS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    172533 BHR ACETABULAR CUP NXT SMITH & NEPHEW ORTHOPAEDICS, LTD. 93582 023

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Hospitalization| R PART NUMBER: 74121150, LOT NUMBER: NI| FEMORAL HEAD, # 74121150, # 08CW16449 022