BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACETLR CUP HAP 54MM W/ IMPTR

    MDR report key: 4855157 · Received June 19, 2015

    Report

    Report Number
    3005477969-2015-00177
    Event Type
    Injury
    Date Received
    June 19, 2015
    Date of Event
    March 4, 2014
    Report Date
    June 20, 2020
    Manufacturer
    SMITH & NEPHEW ORTHOPAEDICS LTD
    Product Code
    NXT
    PMA / PMN Number
    P040033
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    BILATERAL BHRS IMPLANTED. THE PATIENT SUFFERS PAIN AND SYMPTOMS OF COBALT POISONING. UPDATE DUE TO PATIENT SUBMITTED MEDWATCH (B)(4) SENT TO FDA STATED: SCHEDULED REVISION SURGERY. THIS CONCERNS TO THE RIGHT HIP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    401119 ACETLR CUP HAP 54MM W/ IMPTR PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL, RESURFACING NXT SMITH & NEPHEW ORTHOPAEDICS LTD 468636

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Hospitalization| R 74121146 RESURF FEM HEAD 46MM 468636.| RESURFACING FEMORAL HEAD 46MM, 74121146/69012.