BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BHR

    MDR report key: 3181246 · Received June 21, 2013

    Report

    Report Number
    3005477969-2013-00256
    Event Type
    Injury
    Date Received
    June 21, 2013
    Date of Event
    March 25, 2013
    Report Date
    June 21, 2013
    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. A GRINDING SENSATION, GROIN PAIN, ELEVATED METAL ION LEVELS AND A FLUID FORMATION AROUND THE HIP JOINT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    282272 BHR DYSPLASIA CUP NXT SMITH & NEPHEW ORTHOPAEDICS LTD 51109

    Patients

    Seq Age Sex Outcome Treatment
    1 26 YR Hospitalization| R MODULAR HEAD, # 74222138 LOT # 10629| FEMORAL STEM, # 71309009, LOT # 06HM19225B| MODULAR SLEEVE, # 74222100, LOT # 07EW11731