BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FSO CERAMIC SHELLS

    MDR report key: 1778611 · Received July 31, 2010

    Report

    Report Number
    1020279-2010-00209
    Event Type
    Injury
    Date Received
    July 31, 2010
    Date of Event
    January 1, 1901
    Report Date
    February 4, 2011
    Manufacturer
    SMITH & NEPHEW, INC. BROOKS MANUFACTURING SITE
    Product Code
    JDH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PURPOSE OF THIS INVESTIGATION WAS TO EVALUATE THE ALUMINA CERAMIC FEMORAL HEAD, ALUMINA CERAMIC LINER, AND REFLECTION CERAMIC ACETABULAR SHELL. THE AS-RECEIVED COMPONENTS WERE EXAMINED VISUALLY AND MICROSCOPICALLY. NO DESTRUCTIVE TESTING WAS CARRIED OUT. ROUGHENING AND METAL TRANSFER WAS OBSERVED ON THE MAJORITY OF THE ARTICULATING SURFACE OF THE ALUMINA CERAMIC FEMORAL HEAD. SEM/EDXA SPECTRUM ANALYSIS OF THE METAL TRANSFER REGIONS ON THE ARTICULATING SURFACE OF THE ALUMINA CERAMIC FEMORAL HEAD REVEALED SIGNS OF TITANIUM, IRON, AND CHROMIUM. SEM IMAGE ANALYSIS OF THE ROUGHENED REGIONS OF THE ALUMINA CERAMIC FEMORAL HEAD REVEALED SIGNS OF GRAIN PULL-OUT. SEM/EDXA SPECTRUM ANALYSIS OF THE CHAMFER REGION OF THE ALUMINA CERAMIC FEMORAL HEAD REVEALED SIGNS OF TITANIUM. METAL TRANSFER WAS OBSERVED ON THE SUPERIOR SURFACE OF THE RIM AND THE ARTICULATING SURFACE OF THE LINER. SEM/EDXA IMAGE AND SPECTRUM ANALYSIS OF THE SUPERIOR SURFACE OF THE RIM REVEALED SIGNS OF TITANIUM, IRON, AND CHROMIUM. SEM/EDXA SPECTRUM ANALYSIS OF THE ARTICULATING SURFACE OF THE LINER NEAR THE RIM REVEALED SIGNS OF TITANIUM, IRON, CHROMIUM AND NICKEL. THE METAL TRANSFER OBSERVED ON THE ARTICULATING SURFACES OF THE FEMORAL HEAD AND LINER WAS A COMBINATION OF TITANIUM AND ALUMINUM, LIKELY FROM A TI-ALLOY COMPONENT AND IRON AND CHROMIUM, LIKELY FROM A STAINLESS STEEL COMPONENT OR INSTRUMENT. THIS WAS LIKELY DUE TO CONTACT BY EITHER THE HEAD OR LINER WITH TI-ALLOY OR STAINLESS STEEL COMPONENTS AND SUBSEQUENT ARTICULATION BETWEEN THE HEAD AND LINER. THE GRAIN PULL-OUT OBSERVED ON THE FEMORAL HEAD WAS LIKELY DUE TO THE ARTICULATION OF THE TWO COMPONENTS IN THE METAL TRANSFER REGION.

    Description of Event or Problem · 1

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

    Description of Event or Problem · 1

    REVISION DUE TO MIGRATION OF THE ACETABULAR CUP. THE PATIENT WAS EXPERIENCING PAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FSO CERAMIC SHELLS RF FSO CER ACET COMP 52MM JDH SMITH & NEPHEW, INC. BROOKS MANUFACTURING SITE 90102282

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR Hospitalization| R PRODUCT NUMBER: 71332052, LOT NUMBER: 90102282