BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HALF RING 180 MM

    MDR report key: 2981211 · Received February 27, 2013

    Report

    Report Number
    1020279-2013-00132
    Event Type
    Injury
    Date Received
    February 27, 2013
    Date of Event
    February 21, 2013
    Report Date
    February 22, 2013
    Manufacturer
    SMITH & NEPHEW, INC.
    Product Code
    KTT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE AFFECTED DEVICE(S) WAS RETURNED AND EVALUATED TO DETERMINE THE CAUSE OF THE REPORTED INCIDENT. FROM THE ANALYSES CONDUCTED DURING THIS INVESTIGATION, IT WAS CONCLUDED THAT THE TAYLOR SPATIAL FRAMETM HALF RING FRACTURED BY THE INITIATION AND SUBSEQUENT PROPAGATION OF FATIGUE CRACKING. THE FATIGUE CRACKING EVENTUALLY PROPAGATED TO AN EXTENT THAT THE HALF RING WAS UNABLE TO BEAR THE IMPOSED PATIENT LOADING. FATIGUE CRACKING IS CAUSED BY THE HALF RING BEARING CYCLIC (I.E. REPEATED) STRESSES IN EXCESS OF THE MATERIAL ENDURANCE LIMIT FOR AN EXTENDED PERIOD OF TIME. THESE EXCESSIVE CYCLIC STRESSES MAY BE CAUSED BY ANY NUMBER OF CONDITIONS, INCLUDING BUT NOT LIMITED TO: APPLICATION OF TENSILE OR TORSIONAL LOADS IN EXCESS OF THE MATERIAL'S STRENGTH, EXCESSIVE PATIENT ACTIVITY LEVELS PRIOR TO FULL BONE UNION, AND/OR POOR BONE QUALITY. NO MATERIALS OR MANUFACTURING DEVIATIONS WERE FOUND IN THIS INVESTIGATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A REVISION SURGERY WS PERFORMED DUE TO BREAKAGE OF FRAME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    84496 HALF RING 180 MM HALF RING 180 MM KTT SMITH & NEPHEW, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention