BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIPOLAR

    MDR report key: 3771079 · Received April 24, 2014

    Report

    Report Number
    1020279-2014-00280
    Event Type
    Injury
    Date Received
    April 24, 2014
    Date of Event
    April 3, 2014
    Report Date
    April 4, 2014
    Manufacturer
    SMITH & NEPHEW, INC.
    Product Code
    JDH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    VISUAL INSPECTION OF THE RETURNED COMPONENTS SHOWED DAMAGE ON THE UNDERSIDE AND ARTICULATING SURFACE OF THE OXINIUM FEMORAL HEAD. DAMAGE WAS NOTED ON THE POLY LINER, RETAINER RING, AND FEMORAL HEAD OF THE TANDEM BIPOLAR SHELL. ALSO NOTED WAS DAMAGE TO THE EDGE OF THE LOCK RING. FROM THE ANALYSIS CONDUCTED DURING THIS INVESTIGATION, IT WAS CONCLUDED THAT THE ARTICULATING SURFACE OF THE OXINIUM FEMORAL HEAD WAS LIKELY DAMAGED DURING THE REPORTED DISASSOCIATION. METAL TRANSFER OBSERVED IN THE DAMAGED AREA WAS CONSISTENT WITH THE MATERIAL USED IN THE RETAINER RING. THE DAMAGE TO THE UNDERSIDE OF THE OXINIUM FEMORAL HEAD WAS LIKELY DUE TO INSTRUMENT CONTACT UPON REMOVAL. BASED ON THE INFORMATION PROVIDED, THE EXACT CAUSE FOR THE DISASSOCIATION COULD NOT BE DETERMINED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT REVISION SURGERY WAS PERFORMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    249964 BIPOLAR FEMORAL COMPONENT JDH SMITH & NEPHEW, INC. 13FM14519

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization