BEUDAMED
    FDA Adverse Event Injury Summary report: N

    JOURNEY BCS

    MDR report key: 1812915 · Received August 24, 2010

    Report

    Report Number
    1020279-2010-00239
    Event Type
    Injury
    Date Received
    August 24, 2010
    Report Date
    February 28, 2011
    Manufacturer
    SMITH & NEPHEW, INC., BROOKS MANUFACTURING SITE
    Product Code
    JWH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PURPOSE OF THE INVESTIGATION WAS TO ANALYZE THE RETRIEVED JOURNEY BI-CRUCIATE STABILIZED TIBIAL INSERTS. MACROSCOPIC PHOTO ANALYSIS WAS PERFORMED ON THE RETRIEVED INSERT. UPON VISUAL EXAMINATION, THE AS-RECEIVED JOURNEY BCS RIGHT INSERT SHOWED BURNISHING AND ABRASIVE WEAR WERE OBSERVED IN THE ARTICULATING AREAS. GOUGING CAUSED BY A THIRD BODY WAS OBSERVED IN THE ARTICULATING AREAS. CIRCULAR MARKS WERE OBSERVED ON THE DISTAL SURFACE SUGGESTING THAT THE INSERT MAY HAVE BEEN AUTOCLAVED. BOTH SIDES OF THE ANTERIOR LOCKING MECHANISM SHOWED MILD ROUNDING WHICH IS CONSISTENT WITH AN INSERT THAT WAS LOCKED IN THE TIBIAL BASE. MILD BURNISHING AND IMPINGEMENT WERE OBSERVED ON THE ANTEROLATERAL SIDE OF THE POST. A JOURNEY BCS INSERT 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 THE MIDDLE TO THE TOP OF THE POSTERIOR SIDE OF THE POST SUGGESTING THAT THE FEMORAL COMPONENT WAS SLIDING ALONG THE POST IN THE PROXIMAL-DISTAL DIRECTION DUE TO A DEGREE SOFT TISSUE LAXITY. UPON VISUAL EXAMINATION, THE AS-RECEIVED JOURNEY BCS LEFT INSERT SHOWED BURNISHING AND ABRASIVE WEAR WERE OBSERVED IN THE ARTICULATING AREAS. THE MEDIAL ARTICULAR AREA WAS LOCATED MORE ANTERIORLY THAN THAT IS TYPICALLY SEEN IN OTHER RETRIEVED JOURNEY INSERTS SUGGESTING THAT A COMBINATION OF INTERNAL ROTATION OF THE INSERT AND/OR EXTERNAL ROTATION OF THE FEMORAL COMPONENT MAY HAVE OCCURRED. CIRCULAR MARKS WERE OBSERVED ON THE DISTAL SURFACE SUGGESTING THAT THE INSERT MAY HAVE BEEN AUTOCLAVED. BOTH SIDES OF THE ANTERIOR LOCKING MECHANISM SHOWED MILD ROUNDING WHICH IS CONSISTENT WITH AN INSERT THAT WAS LOCKED IN THE TIBIAL BASE. MILD BURNISHING AND IMPINGEMENT WERE OBSERVED ON THE ANTEROLATERAL SIDE OF THE POST. A JOURNEY BCS INSERT 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 THE MIDDLE TO THE TOP OF THE POSTERIOR SIDE OF THE POST SUGGESTING THAT THE FEMORAL COMPONENT WAS SLIDING ALONG THE POST IN THE PROXIMAL-DISTAL DIRECTION DUE TO A DEGREE SOFT TISSUE LAXITY. IT WAS REPORTED THAT THE REVISION SURGERIES WERE PERFORMED DUE TO DISLOCATION OF ONE KNEE AND INSTABILITY OF THE OTHER KNEE. IN CONCLUSION, THE INSERTS SHOWED FEATURES CONSISTENT WITH INSTABILITY OF THE JOINT. CORRECTED AND ADDITIONAL DATA: THE REVISION PERFORMED WAS A BI-LATERAL REVISION. THIS WAS THE SECOND REVISION FOR BOTH KNEES. THE INITIAL IMPLANT DATE PROVIDED WAS FOR THE INITIAL REVISION OF THE RIGHT KNEE. THIS REVISION WAS REPORTED UNDER REPORT NUMBER 1020279-2010-00238. THE INITIAL REVISION OF THE LEFT WAS REPORTED UNDER REPORT NUMBER 1020279-2011-00025. IN ADDITION, THE PART AND LOT NUMBER PROVIDED WAS ALSO INCORRECT. THE CORRECT PART AND LOT NUMBERS HAVE BEEN PROVIDED ON THIS FOLLOW-UP REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT REVISION SURGERY WILL BE PERFORMED DUE TO DISLOCATION. THIS WILL BE THE PATIENT'S SECOND REVISION DUE TO DISLOCATION. THE FIRST REVISION SURGERY IS CAPTURED UNDER MEDWATCH REPORT # 1020279-2010-00238.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 JOURNEY BCS TIBIAL INSERT JWH SMITH & NEPHEW, INC., BROOKS MANUFACTURING SITE 06AM15243

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Hospitalization| R PART # 74023235, LOT # 08GM08328