BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BHR

    MDR report key: 3133275 · Received May 29, 2013

    Report

    Report Number
    3005477969-2013-00213
    Event Type
    Injury
    Date Received
    May 29, 2013
    Date of Event
    July 7, 2011
    Report Date
    July 24, 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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT REVISION SURGERY WAS PERFORMED DUE TO FEMORAL NECK FRACTURE. IN (B)(6) 2009 SYMPTOMS OF GROIN PAIN, CLUNKING AND GRINDING, DIFFICULTY WALKING DEVELOPED. (B)(6) 2011 PATIENT SENT TO HOSPITAL FOLLOWING PAIN AND INABILITY TO BEAR WEIGHT. ADVERSE REACTION TO METAL DEBRIS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    235496 BHR ACETABULAR CUP NXT SMITH & NEPHEW ORTHOPAEDICS LTD 079484

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Hospitalization| R FEMORAL HEAD, PART # 74121146, LOT # 67314