BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BHR

    MDR report key: 3020705 · Received March 26, 2013

    Report

    Report Number
    3005477969-2013-00113
    Event Type
    Injury
    Date Received
    March 26, 2013
    Date of Event
    January 24, 2013
    Report Date
    May 17, 2013
    Manufacturer
    SMITH & NEPHEW ORTHOPAEDICS LTD
    Product Code
    NXT
    PMA / PMN Number
    P040033
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT REVISION SURGERY WAS PERFORMED DUE TO PAIN AND A POSSIBLE METAL ALLERGY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    123469 BHR ACETABULAR CUP NXT SMITH & NEPHEW ORTHOPAEDICS LTD 07HW13107

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Hospitalization| R MODULAR SLEEVE, PART AND LOT # UNKNOWN| MODULAR HEAD, PART AND LOT # UNKNOWN| MODULAR SLEEVE, # 74222200, LOT # 07FW11740| MODULAR HEAD, # 74222144, LOT # 07JW13777 012