BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NO 4. TRIATHLON TS PLUS TIBIAL INSERT X3 POLY 11MM

    MDR report key: 4123288 · Received September 26, 2014

    Report

    Report Number
    0002249697-2014-03637
    Event Type
    Injury
    Date Received
    September 26, 2014
    Date of Event
    June 16, 2014
    Report Date
    September 2, 2014
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    JWH
    PMA / PMN Number
    K072221
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE HISTORY REVIEW: REVIEW OF THE DEVICE HISTORY RECORDS INDICATE DEVICES WERE MANUFACTURED AND ACCEPTED INTO FINAL STOCK WITH NO REPORTED DISCREPANCIES. COMPLAINT HISTORY REVIEW: THERE HAVE BEEN NO OTHER EVENTS REPORTED FOR THE REPORTED MANUFACTURING LOT. THE EVENT COULD NOT BE CONFIRMED NOR THE ROOT CAUSE OF THE REPORTED EVENT DETERMINED DUE TO THE MINIMAL INFORMATION RECEIVED. A CAPA TREND ANALYSIS WAS CONDUCTED FOR THE REPORTED FAILURE MODE AND CONCLUDED INFECTION IS MOST LIKELY A RESULT FROM OTHER FACTORS NOT NECESSARILY RELATED TO THE DEVICE IN THE HEALTHCARE FACILITY SETTING.

    Additional Manufacturer Narrative · 1

    THE FOLLOWING OTHER DEVICES WERE ALSO LISTED IN THIS REPORT: UNKNOWN FEMORAL COMPONENT; UNKNOWN TIBIAL COMPONENT. IT CANNOT BE DETERMINED WHICH, IF ANY OF THESE DEVICES MAY HAVE CAUSED OR CONTRIBUTED TO THE PATIENT'S INFECTION. AN EVALUATION OF THE DEVICE CANNOT BE PERFORMED AS THE DEVICE WAS NOT RETURNED TO THE MANUFACTURER. ADDITIONAL INFORMATION HAS BEEN REQUESTED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE IT WILL BE REPORTED IN A SUPPLEMENTAL REPORT UPON COMPLETION OF THE INVESTIGATION. NOT RETURNED TO THE MANUFACTURER.

    Description of Event or Problem · 1

    POSTOPERATIVE DIAGNOSIS: PATIENT UNDERWENT PRIMARY TKA ON (B)(6) 2012 AND SUBSEQUENT I&D WASHOUT ON (B)(6) 2014 WHICH INCLUDED LINER EXCHANGE. PATIENT REMAINED INFECTED AND UNDERWENT REVISION (B)(6) 2014. FEMORAL AND TIBIAL COMPONENTS ORIGINALLY IMPLANTED (B)(6) 2012 REMOVED AS WELL AS LINER WHICH WAS IMPLANTED ON (B)(6) 2014.

    Description of Event or Problem · 1

    POSTOPERTIVE DIAGNOSIS: PATIENT UNDERWENT PRIMARY TKA (B)(6) 2012 AND SUBSEQUENT I&D WASHOUT ON (B)(6) 2014 WHICH INCLUDED LINER EXCHANGE. PATIENT REMAINED INFECTED AND UNDERWENT REVISION (B)(6) 2014. FEMORAL AND TIBIAL COMPONENTS ORIGINALLY IMPLANTED (B)(6) 2012 REMOVED AS WELL AS LINER WHICH WAS IMPLANTED (B)(6) 2014.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    602496 NO 4. TRIATHLON TS PLUS TIBIAL INSERT X3 POLY 11MM IMPLANT JWH STRYKER ORTHOPAEDICS-MAHWAH MMD1JY

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Required Intervention