BEUDAMED
    FDA Adverse Event Injury Summary report: N

    R3 42MM ID INTL COCR LINER 54MM

    MDR report key: 6452621 · Received April 3, 2017

    Report

    Report Number
    3005477969-2017-00002
    Event Type
    Injury
    Date Received
    April 3, 2017
    Date of Event
    October 27, 2016
    Report Date
    June 21, 2017
    Manufacturer
    SMITH & NEPHEW ORTHOPAEDICS LTD
    Product Code
    NXT
    PMA / PMN Number
    P040033
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DA
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    REPORTED METAL LEVELS OF CR:7.82UG/L, CO:20.2UG/L (B)(6) 2016. DEVICES REMAIN IMPLANTED, NO INDICATION OF REVISION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    235274 R3 42MM ID INTL COCR LINER 54MM PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL, RESURFACING NXT SMITH & NEPHEW ORTHOPAEDICS LTD 08JW18738

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR MODULAR SLEEVE#74222200, LOT UNKNOWN| R3 0 HOLE ACET SHELL#71331854, LOT#08FM17552| STEM#71306611, LOT#08AM14853