BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BHR

    MDR report key: 3132623 · Received May 29, 2013

    Report

    Report Number
    3005477969-2013-00218
    Event Type
    Injury
    Date Received
    May 29, 2013
    Date of Event
    March 15, 2013
    Report Date
    May 6, 2014
    Manufacturer
    SMITH & NEPHEW ORTHOPAEDICS LTD
    Product Code
    NXT
    PMA / PMN Number
    P040033
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT REVISION SURGERY WAS PERFORMED AROUND THE END OF 2012 DUE TO WEAR, NECROSIS AND PAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    235646 BHR ACETABULAR CUP NXT SMITH & NEPHEW ORTHOPAEDICS LTD 69331 012

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Hospitalization| R FEMORAL HEAD, PART # 74121142, LOT # 66993| FEMORAL HEAD, PART# 74121142, LOT 68066 047