BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BCS POLY

    MDR report key: 2005121 · Received March 2, 2011

    Report

    Report Number
    1020279-2011-00060
    Event Type
    Injury
    Date Received
    March 2, 2011
    Date of Event
    February 1, 2011
    Report Date
    March 2, 2011
    Manufacturer
    SMITH & NEPHEW, INC.
    Product Code
    JWH
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PURPOSE OF THIS INVESTIGATION WAS TO ANALYZE THE DEFORMATION AND WEAR OBSERVED ON THE RETRIEVED JOURNEY BI-CRUCIATE STABILIZED (BCS) INSERT. MACROSCOPIC PHOTO ANALYSIS AND DIMENSIONAL INSPECTION WERE PERFORMED ON THE RETRIEVED INSERT. THE INSERT HAS BURNISHED AREAS ON THE ARTICULATION SURFACES. BURNISHING ON THE ARTICULATING SURFACES WAS MORE WIDESPREAD ON THE MEDIAL SIDE THAN LATERAL SIDE IN ANTERIOR/POSTERIOR DIRECTION. THE BCS POST SHOWED DEFORMATION AND BURNISHING ON THE POSTERIOR SIDE. A JOURNEY BCS INSERT POST WOULD TYPICALLY SHOW A CONTACT PATCH ON THE POSTERIOR SIDE OF THE POST CENTERED IN THE PROXIMAL-DISTAL DIRECTION. THE RETRIEVED INSERT SHOWED AN AREA OF BURNISHING AND DEFORMATION FROM CENTER AND UPWARDS OF THE POST SUGGESTING THAT THE FEMORAL COMPONENT WAS SLIDING ALONG THE POST IN THE PROXIMAL-DISTAL DIRECTION. THIS BURNISHING SEEN ON THE TIBIAL INSERT POST INDICATE A DEGREE OF LAXITY IN THE JOINT.

    Additional Manufacturer Narrative · 1

    SMITH & NEPHEW, INC. IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED UPON INFORMATION WHICH SMITH & NEPHEW, INC. HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY FDA, SMITH & NEPHEW, INC., OR ITS EMPLOYEES, THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, SMITH & NEPHEW, INC., OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A REVISION WAS PERFORMED DUE TO FLEXION INSTABILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BCS POLY JOURN ART INS BCS STD 5-6 LT13 JWH SMITH & NEPHEW, INC. 09CM12535

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Required Intervention