BEUDAMED
    FDA Adverse Event Injury Summary report: N

    JOURNEY FEM OX NP BCS LT SZ 7

    MDR report key: 4153217 · Received October 8, 2014

    Report

    Report Number
    1020279-2014-00628
    Event Type
    Injury
    Date Received
    October 8, 2014
    Date of Event
    October 2, 2014
    Report Date
    October 7, 2014
    Manufacturer
    SMITH & NEPHEW, INC.
    Product Code
    JWH
    PMA / PMN Number
    K042515
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE ASSOCIATED DEVICE WAS RETURNED AND EVALUATED. THE VISUAL INSPECTION OF THE RETURNED DEVICES SHOW PITTING ON THE INSERT AND WEAR ON THE TIBIAL TRAY ON THE BASEPLATE. THE COMPLAINT HISTORY SHOWS NO PRIOR COMPLAINTS FOR THE LISTED LOTS. A DIMENSIONAL INSPECTION WAS COMPLETED AND THE TIBIAL BASE AND THE DIMENSIONS WERE WITHIN SPECIFICATIONS HOWEVER DAMAGE/DEFORMATION AT SEVERAL FEATURES OF THE INSERT WOULD NOT ALLOW FOR ACCURATE MEASUREMENT. THE LAB ANALYSIS CONCLUDED THAT THE POLYETHYLENE INSERT HAD DEFORMATION ON THE ARTICULATING SURFACE AND ROUGHENING OF THE BACKSIDE THAT COULD HAVE BEEN CAUSED DUE TO THIRD BODY DEBRIS SUCH AS BONE OR BONE CEMENT. AS A SIMPLE TEST FOR ADHESION, A SMALL AMOUNT OF BONE CEMENT WAS PLACED ON THE UNDERSIDE OF THE TIBIAL BASEPLATE AND ALLOWED TO CURE FOR APPROXIMATELY 30 MINUTES. THE CEMENT DID NOT DISSOCIATE FROM THE BASEPLATE WITH THE APPLICATION OF MANUAL FORCE. VISUAL ANALYSIS OF THE COMPONENTS DID NOT REVEAL ANY FEATURES THAT WOULD HAVE CONTRIBUTED TO THE LOOSENING OF THE TIBIAL TRAY. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. A REVIEW OF THE MANUFACTURING RECORDS DID NOT REVEAL ANY MANUFACTURING OR MATERIAL ABNORMALITIES THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED INCIDENT. AT THIS TIME, WE HAVE NO REASON TO SUSPECT THAT THE PRODUCT FAILED TO MEET ANY PRODUCT SPECIFICATIONS AT THE TIME OF MANUFACTURE. THIS INVESTIGATION COULD NOT VERIFY OR IDENTIFY ANY EVIDENCE OF PRODUCT CONTRIBUTION TO THE REPORTED PROBLEM. BASED ON THIS INVESTIGATION, THE NEED FOR CORRECTIVE ACTION IS NOT INDICATED. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE COMPLAINT WILL BE REOPENED. WE CONSIDER THIS INVESTIGATION CLOSED.

    Additional Manufacturer Narrative · 1

    .

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED DUE TO LOOSENING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    630754 JOURNEY FEM OX NP BCS LT SZ 7 KNEE PROSTHESIS JWH SMITH & NEPHEW, INC. 09DM08692

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Required Intervention (B)(4)