BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BHR

    MDR report key: 2923691 · Received January 22, 2013

    Report

    Report Number
    3005477969-2013-00029
    Event Type
    Injury
    Date Received
    January 22, 2013
    Date of Event
    August 26, 2011
    Report Date
    March 7, 2013
    Manufacturer
    SMITH & NEPHEW ORTHOPAEDICS LTD
    Product Code
    NXT
    PMA / PMN Number
    P040033
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CATALOG NUMBER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT REVISION SURGERY WAS PERFORMED DUE TO PAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    30480 BHR ACETABULAR CUP NXT SMITH & NEPHEW ORTHOPAEDICS LTD 7658

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Hospitalization| R FEMORAL HEAD, PART# 121150, LOT# 10079| FEMORAL HEAD, PART # 74121150, LOT # UNKNOWN