BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BHR

    MDR report key: 1931257 · Received December 17, 2010

    Report

    Report Number
    3005477969-2010-00228
    Event Type
    Injury
    Date Received
    December 17, 2010
    Date of Event
    November 22, 2010
    Report Date
    April 12, 2011
    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 IS SCHEDULED FOR A PATIENT WITH BILATERAL BHR IMPLANTS WHO REPORTEDLY HAS ELEVATED BLOOD METAL IONS. THE PATIENT IS SCHEDULED TO HAVE A BILATERAL REVISION IN (B)(6) 2011.

    Description of Event or Problem · 1

    REVISION SURGERY PERFORMED ON (B)(6) 2011.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BHR ACETABULAR CUP NXT SMITH & NEPHEW ORTHOPAEDICS, LTD. 30047 034

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Hospitalization| R FEMORAL HEAD, PART # 74121142, LOT # 0532 131| FEMORAL HEAD, EXACT PART AND LOT UNKNOWN