BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BHR

    MDR report key: 2140279 · Received June 27, 2011

    Report

    Report Number
    3005477969-2011-00123
    Event Type
    Injury
    Date Received
    June 27, 2011
    Date of Event
    March 18, 2010
    Report Date
    February 17, 2014
    Manufacturer
    SMITH & NEPHEW ORTHOPAEDICS, LTD.
    Product Code
    NXT
    PMA / PMN Number
    P040033
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT WAS REPORTED TO THE MANUFACTURER VIA US FDA MEDWATCH REFERENCE# (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED FOLLOWING REPEATED HIP DISLOCATION. CHRONIC INFECTION FOLLOWED REVISION REQUIRING ADDITIONAL MEDICAL INTERVENTION AND APPROXIMATELY 9 MONTHS OF HOSPITALIZATION. THE HIP REVISION IS BELIEVED TO HAVE OCCURRED IN 2009 OR 2010, BUT EXACT DETAILS HAVE NOT BEEN PROVIDED TO THE MANUFACTURER.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R FEMORAL HEAD, PART#74121146, LOT UNKNOWN