BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BHR

    MDR report key: 2136199 · Received June 22, 2011

    Report

    Report Number
    3005477969-2011-00122
    Event Type
    Injury
    Date Received
    June 22, 2011
    Date of Event
    June 20, 2011
    Report Date
    June 22, 2011
    Manufacturer
    SMITH & NEPHEW ORTHOPAEDICS, LTD.
    Product Code
    NXT
    PMA / PMN Number
    P040033
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT RESURFACING FEMORAL HEAD REVISION SURGERY PERFORMED DUE TO COLLAPSE FOR AVN (AVASCULAR NECROSIS). IT APPEARS THE ACETABULAR CUP ORIGINALLY IMPLANTED ON (B)(6) 2009 HAS REMAINED IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BHR RESURFACING FEMORAL HEAD NXT SMITH & NEPHEW ORTHOPAEDICS, LTD. 088324

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Hospitalization| R ACETABULAR CUP, PART AND LOT# UNKNOWN