BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRIATHLON PS X3 TIBIAL INSERT

    MDR report key: 2963756 · Received February 15, 2013

    Report

    Report Number
    0002249697-2013-00692
    Event Type
    Injury
    Date Received
    February 15, 2013
    Date of Event
    January 28, 2013
    Report Date
    January 28, 2013
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    JWH
    PMA / PMN Number
    K051146
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VT, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE EVENT WAS NOT CONFIRMED AS DEVICE WAS NOT RETURNED FOR ANALYSIS AND NO MEDICAL RECORDS WERE PROVIDED FOR EVALUATION. DEVICE HISTORY REVIEW INDICATES ALL DEVICES WERE MANUFACTURED AND ACCEPTED INTO FINAL STOCK WITH NO REPORTED DISCREPANCIES. COMPLAINT HISTORY REVIEW INDICATED THERE HAVE BEEN NO OTHER EVENTS FOR THIS LOT. REVIEW OF THE STERILIZATION RECORDS VERIFIED THE STERILITY OF THE REPORTED PRODUCT LOTS. IT IS NOTED THAT WHEN THE DOUBLE BARRIER PACKAGING IS OPENED, THE STERILITY OF ANY DEVICE BECOMES A FUNCTION OF HANDLING AND SURGICAL TECHNIQUE AND IS BEYOND STRYKER'S CONTROL.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IF RECEIVED WILL BE PROVIDED IN A SUPPLEMENTAL REPORT. CATALOG NUMBERS AND LOT CODES OF OTHER DEVICES LISTED IN THIS REPORT: CAT #: 5515-F-602, LOT #: FNIV, DESCRIPTION: TRIATHLON PS FEM COMPONENT, CEMENTED; CAT #: 5521-B-600, LOT #: EHOG, DESCRIPTION: TRI TS BASEPLATE SIZE 6; CAT #: 5560-S-112, LOT #: N5T14P, DESCRIPTION: TRI CEMENTED STEM 12 MM X 50 MM; CAT #: 5551-G-401: LOT # D593, DESCRIPTION: TRIATHLON ASYMMETRIC X3 PATELLA. IT CANNOT BE DETERMINED WHICH, IF ANY OF THESE DEVICES MAY HAVE CAUSED OR CONTRIBUTED TO THE PATIENT'S INFECTION. HOSPITAL WILL NOT RELEASE.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT WAS DIAGNOSED WITH AN INFECTION SO THE DEVICES WERE REMOVED AND ANTIBIOTIC SPACERS WERE IMPLANTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT WAS DIAGNOSED WITH AN INFECTION SO THE DEVICES WERE REMOVED AND ANTIBIOTIC SPACERS WERE IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    68714 TRIATHLON PS X3 TIBIAL INSERT IMPLANT JWH STRYKER ORTHOPAEDICS-MAHWAH MKLX8W

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Required Intervention