BEUDAMED
    FDA Adverse Event Injury Summary report: N

    R3

    MDR report key: 3132733 · Received May 29, 2013

    Report

    Report Number
    3005477969-2013-00215
    Event Type
    Injury
    Date Received
    May 29, 2013
    Date of Event
    August 5, 2013
    Report Date
    April 8, 2015
    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

    Additional Manufacturer Narrative · 1

    .

    Description of Event or Problem · 1

    IT WAS REPORTED THAT REVISION SURGERY IS SCHEDULED TO BE PERFORMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    234940 R3 COCR ACETABULAR LINER NXT SMITH & NEPHEW ORTHOPAEDICS LTD 09AW21251

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Hospitalization| R FEMORAL STEM, # (B)(4), LOT # 08MM19966A| ACETABULAR SHELL, # (B)(4), LOT # 09BM01029A| MODULAR SLEEVE, # (B)(4), LOT # 08KW19689| MODULAR HEAD # (B)(4), LOT # 09CW22735