BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRIATHLON PS X3 TIBIAL INSERT

    MDR report key: 3120660 · Received May 20, 2013

    Report

    Report Number
    0002249697-2013-01724
    Event Type
    Injury
    Date Received
    May 20, 2013
    Date of Event
    January 1, 2013
    Report Date
    April 26, 2013
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    JWH
    PMA / PMN Number
    K051146
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CATALOG NUMBERS AND LOT CODES OF OTHER DEVICES LISTED IN THIS REPORT: CAT # 5515-F-401, LOT # WSWG, DESCRIPTION: TRIATHLON PS FEM COMPONENT, CEMENTED; CAT # 5520-B-400, LOT # AUIW, DESCRIPTION: TRIATHLON PRIM TIB BASEPLATE - CEMENTED; CAT # 5551-G-299 LOT # 0K92, DESCRIPTION: TRIATHLON ASYMMETRIC X3 PATELLA. AT THIS TIME, IT CANNOT BE DETERMINED IF THIS DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE PATIENT¿S EXPERIENCE. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IF RECEIVED WILL BE PROVIDED IN A SUPPLEMENTAL REPORT.

    Additional Manufacturer Narrative · 1

    THERE WERE NO REPORTED DISCREPANCIES AND THERE WERE NO OTHER EVENTS FOR THE REFERENCED LOT. DEVICE EVALUATION COULD NOT BE PERFORMED AS NO ITEMS ASSOCIATED WITH THE EVENT WERE RETURNED OR MADE AVAILABLE FOR IDENTIFICATION OR EVALUATION. THE SOURCE OF THE INFECTION COULD NOT BE DETERMINED AS PATIENT INFORMATION, CLINICAL HISTORY, AND RESULTS OF BLOODWORK FOR INFECTION WERE NOT PROVIDED. 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. THE REPORTED EVENT REGARDING INFECTION INVOLVING A TRIATHLON INSERT WAS NOT CONFIRMED.

    Description of Event or Problem · 1

    THE PATIENT DEVELOPED AN INFECTED KNEE APPROXIMATELY TWO WEEKS AFTER 2 ROOT CANALS IN (B)(6) 2013. FLUID WAS REMOVED FROM THE KNEE AND THE PATIENT IS AWAITING ADDITIONAL TEST RESULTS. AN UPCOMING REVISION SURGERY TO REMOVE IMPLANTS AND IMPLANTATION OF AN ANTIBIOTIC SPACER IS EXPECTED.

    Description of Event or Problem · 1

    THE PATIENT DEVELOPED AN INFECTED KNEE APPROXIMATELY TWO WEEKS AFTER 2 ROOT CANALS IN MID (B)(6) 2013. FLUID WAS REMOVED FROM THE KNEE AND THE PATIENT IS AWAITING ADDITIONAL TEST RESULTS. AN UPCOMING REVISION SURGERY TO REMOVE IMPLANTS AND IMPLANTATION OF AN ANTIBIOTIC SPACER IS EXPECTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    221480 TRIATHLON PS X3 TIBIAL INSERT IMPLANT JWH STRYKER ORTHOPAEDICS-MAHWAH MKHPE0

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Required Intervention