BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BHR

    MDR report key: 3792086 · Received May 6, 2014

    Report

    Report Number
    3005477969-2014-00298
    Event Type
    Injury
    Date Received
    May 6, 2014
    Date of Event
    July 23, 2014
    Report Date
    June 5, 2014
    Manufacturer
    SMITH & NEPHEW
    Product Code
    NXT
    PMA / PMN Number
    P040033
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT REVISION SURGERY IS SCHEDULED TO BE PERFORMED. THE PATIENT REPORTEDLY STARTED EXPERIENCING PAIN IN (B)(6) 2010.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    270491 BHR ACETABULAR CUP NXT SMITH & NEPHEW 092561

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Hospitalization| R HEMI HEAD, # 74122546, LOT # 08CW15889| FEMORAL STEM, # 71306111, LOT # 09FM21245| FEMORAL HEAD, PART AND LOT # UNKNOWN| MODULAR SLEEVE, # 74222100, LOT # 08JW19026