BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GENESIS II

    MDR report key: 2000409 · Received February 24, 2011

    Report

    Report Number
    8010764-2011-00005
    Event Type
    Injury
    Date Received
    February 24, 2011
    Date of Event
    January 24, 2011
    Report Date
    June 21, 2011
    Manufacturer
    SMITH & NEPHEW, INC
    Product Code
    JWH
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PURPOSE OF THIS INVESTIGATION WAS TO ANALYZE THE RETRIEVED GENESIS PS HF INSERT. MACROSCOPIC PHOTO ANALYSIS AND DIMENSIONAL INSPECTION WERE PERFORMED ON THE RETRIEVED INSERT. THE CRITICAL DIMENSIONS OF THE INSERT WERE CHECKED AGAINST THE IPUSING STANDARD INSTRUMENTS. DIMENSIONAL ANALYSIS OF THE INSERT SHOWED THE T-U DEPTH AND HEIGHT/ANTERIOR LOCK DETAIL WERE WITHIN SPECIFICATION. THE PERIPHERY, LOCKING DETAIL, A-P WIDTH, M-L WIDTH OVERALL, DOVETAIL AND LOCKING DETAIL DIMENSIONS COULD NOT BE MEASURED DUE TO THE DEFORMATION PRESENT. THE INSERT HAS ABRASIVE WEAR, BURNISHING AND PITTING ON THE ARTICULATION SURFACES. THE INSERT HAS A ROUGHENED AND WORN AREA POSTERIORLY ON THE MEDIAL CONDYLE LIKELY DUE TO CONTACT WITH BONE AFTER DISLOCATION. THE DISTAL SURFACE OF THE INSERT HAS INSTRUMENT DAMAGES LIKELY OCCURRED DURING EXPLANTATION. THE POST HAS DEFORMATION AND ROUGH WORN AREAS ON THE ANTERIOR SIDE LIKELY DUE TO CONTACT WITH BONE AND/OR FEMORAL COMPONENT. THE POSTERIOR SIDE OF THE PS POST HAS BURNISHED REGIONS LIKELY OCCURRED DUE TO ARTICULATION. BASED ON EXAMINATION OF THE RETURNED POLYETHYLENE INSERT THE EXACT REASONS FOR FEMORAL COMPONENT DISLOCATING ON THE PS POST COULD NOT BE DETERMINED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A REVISION SURGERY WAS REQUIRED DUE TO IMPLANT DISLOCATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GENESIS II GII PS HI FLEX ISRT SZ 1-2 9 JWH SMITH & NEPHEW, INC 07BT06596

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Required Intervention (B)(4)