BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HIP IMPLANT

    MDR report key: 3040452 · Received April 8, 2013

    Report

    Report Number
    1020279-2013-00200
    Event Type
    Injury
    Date Received
    April 8, 2013
    Date of Event
    March 22, 2013
    Report Date
    March 22, 2013
    Manufacturer
    SMITH & NEPHEW, INC.
    Product Code
    JDH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SF
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE AFFECTED DEVICES WERE RETURNED AND EVALUATED. THEY WERE EXAMINED VISUALLY AND MACROSCOPICALLY. NO DESTRUCTIVE TESTING WAS PERFORMED. THE BONE CONTACTING SURFACE OF THE SHELL HAS NO BONE GROWTH ON THE SURFACE. THE POLISHED INSIDE SURFACE OF THE SHELL AND THE OUTER SURFACE OF THE POLYETHYLENE LINER THAT WAS LOCKED INTO SHELL HAVE MILD SCRATCHES ON THE SURFACES THAT LIKELY OCCURRED DURING USAGE DUE TO MICROMOTION BETWEEN THE COMPONENTS. THE FEMORAL HEAD AND LINER ARTICULATING REGIONS HAVE MILD SCRATCHES THAT LIKELY OCCURRED DURING ARTICULATION. NO DAMAGES ON THE FEMORAL HEAD TAPER WERE NOTED. THE SPHERICAL HEAD SCREWS HAVE BURNISHING ON THE SHAFT NEAR THE SCREW HEAD REGION LIKELY DUE TO RUBBING AGAINST THE SHELL. VISUAL INSPECTION OF THE IMPLANTS SHOWED NO FEATURES OR DAMAGES ON THE COMPONENT THAT COULD HAVE CONTRIBUTED TO THE ACETABULAR COMPONENT ROTATION. LACK OF BONE GROWTH ON THE SHELL MAY HAVE CONTRIBUTED TO THE ACETABULAR COMPONENT ROTATION. THE EXACT CAUSE OF THE REPORTED FAILURE COULD NOT BE DETERMINED FROM THE ANALYSIS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED DUE TO ROTATION OF ACETABULAR COMPONENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    144010 HIP IMPLANT R3 3 HOLE ACET SHELL 56MM JDH SMITH & NEPHEW, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR 71335756 LOT 11MM13792, 71343600 LOT 12BM01833| 71335756