BEUDAMED
    FDA Adverse Event Injury Summary report: N

    R3

    MDR report key: 3809616 · Received May 14, 2014

    Report

    Report Number
    3005477969-2014-00326
    Event Type
    Injury
    Date Received
    May 14, 2014
    Date of Event
    February 7, 2014
    Report Date
    May 14, 2014
    Manufacturer
    SMITH & NEPHEW
    Product Code
    NXT
    PMA / PMN Number
    P040033
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    IT HAS BEEN ESTABLISHED THAT THIS INCIDENT HAS PREVIOUSLY BEEN REPORTED VIA A PRIOR MDR 3005477969-2014-00178. PLEASE DISREGARD THIS REDUNDANT REPORT. A FOLLOW UP REPORT FOR THE INCIDENT WILL BE SUBMITTED VIA MDR 3005477969-2014-00178.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT REVISION SURGERY WAS PERFORMED. A SWINGING SENSATION, INCREASING ¿CRACKING¿ IN THE JOINT WHILE WALKING UP THE STAIRS OR UPHILL, INCREASING NOSE BLEEDS, DRYING OF THE SKIN, SWELLING OF THE LOWER LIMBS, BACK PAIN, REDUCED WALKING DISTANCE OF 2KM, BOIL IN THE GROIN, INSOMNIA AND UNCERTAINTY RELATING TO MEMORY REPORTED. THE FEMORAL STEM REMAINS IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    288861 R3 COCR ACETABULAR LINER NXT SMITH & NEPHEW

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R ACETABULAR SHELL, PART AND LOT # UNKNOWN| FEMORAL STEM, PART AND LOT # UNKNOWN| MODULAR SLEEVE, PART AND LOT # UNKNOWN| MODULAR HEAD, PART AND LOT # UNKNOWN