BEUDAMED
    FDA Adverse Event Injury Summary report: N

    1020279-2012-00565

    MDR report key: 2792558 · Received October 16, 2012

    Report

    Report Number
    1020279-2012-00565
    Event Type
    Injury
    Date Received
    October 16, 2012
    Date of Event
    May 12, 2010
    Report Date
    October 12, 2012
    Manufacturer
    SMITH & NEPHEW, INC.
    Product Code
    JWH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CORRECTING DATE OF EVENT DATE FROM (B)(6) 2009 TO (B)(6) 2010; CORRECTING DATE OF THIS REPORT FROM (B)(6) 2012 TO (B)(6) 2012.

    Additional Manufacturer Narrative · 1

    THE RETURNED JOURNEY BCS COMPONENTS WERE EXAMINED VISUALLY AND MICROSCOPICALLY. THE PURPOSE OF THIS INVESTIGATION WAS TO DETERMINE THE CAUSE FOR THE DISLOCATION OF THE FEMORAL COMPONENT. THE OXINIUM FEMORAL COMPONENT HAD DAMAGE ON SEVERAL SURFACES AND BONE CEMENT MATERIAL WAS ADHERED TO THE GRIT BLASTED SURFACE. MICROSCOPIC AND X-RAY ANALYSIS OF A DAMAGED AREA ON THE FEMORAL COMPONENT REVEALED THE PRESENCE OF IRON INDICATING CONTACT WITH A STAINLESS STEEL INSTRUMENTS THAT WOULD HAVE BEEN USED DURING THE REVISION SURGERY. THE TITANIUM TIBIAL TRAY HAD DAMAGE ON BOTH THE POLISHED AND GRIT BLASTED SURFACE THAT WAS LIKELY DUE TO EXPLANTATION. THE JOURNEY BCS ARTICULAR INSERT HAD LITTLE VISIBLE WEAR ON THE ARTICULATING SURFACE. THE INSERT HAD DAMAGE OVER SEVERAL SURFACES THAT WERE MOST LIKELY DUE TO THE EXPLANATION PROCEDURE. THE INSERT APPEARED TO HAVE BEEN WELL FIXED IN THE TIBIAL TRAY. THE POSTERIOR STABILIZED (P/S) POST WAS SAWED OFF DURING THE REVISION AND WAS NOT AVAILABLE FOR ANALYSIS. THE LACK OF THE P/S POST MAKES IT DIFFICULT TO DRAW A CONCLUSION TO THE CAUSE OF THE FEMORAL COMPONENT DISLOCATION AS THE APPEARANCE OF THE POST IN TERMS OF DEFORMATION INDICATES THE DEGREE OF LAXITY IN THE JOINT. THERE WERE NO MATERIALS OR MANUFACTURING DEFECTS SEEN. SAFETY AFFAIRS WILL CONTINUE TO MONITOR THIS DEVICE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A REVISION WAS PERFORMED DUE TO DISLOCATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 JWH SMITH & NEPHEW, INC. 08KM08780

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention (B)(4)| (B)(4)