BEUDAMED
    FDA Adverse Event Injury Summary report: N

    X3 TRIATHLON CS INSERT #5 19MM

    MDR report key: 3880181 · Received June 18, 2014

    Report

    Report Number
    0002249697-2014-02351
    Event Type
    Injury
    Date Received
    June 18, 2014
    Date of Event
    May 21, 2014
    Report Date
    May 21, 2014
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    JWH
    PMA / PMN Number
    K063423
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AN EVENT REGARDING OFF-LABEL USE INVOLVING AN X3 TRIATHLON CS INSERT #5 19MM WAS REPORTED. A REVIEW OF QIN (B)(4) VERSION D INDICATED THAT THE PACKAGING INSERT WHICH WAS PACKAGED WITH THE DEVICE AT THE TIME OF MANUFACTURE, GIVES INFORMATION ABOUT USING PRODUCTS FROM OTHER COMPANIES WITH STRYKER PRODUCTS. THE INSERT STRONGLY ADVISES AGAINST THE USE OF ANOTHER MANUFACTURER¿S TOTAL KNEE COMPONENT WITH ANY OF HOWMEDICA OSTEONICS¿ TOTAL KNEE COMPONENTS. ANY SUCH USE WILL NEGATE THE RESPONSIBILITY OF HOWMEDICA OSTEONICS CORP . FOR THE PERFORMANCE OF THE RESULTING MIXED COMPONENT IMPLANT.¿ BASED ON THE PROVIDED INFORMATION IT HAS BEEN DETERMINED THAT THIS EVENT IS ASSOCIATED WITH AN OFF-LABEL APPLICATION. NO FURTHER INVESTIGATION IS REQUIRED AT THIS TIME.

    Additional Manufacturer Narrative · 1

    AN EVALUATION OF THE DEVICE CANNOT BE PERFORMED AS THE DEVICE WAS NOT RETURNED TO THE MANUFACTURER. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THE EVALUATION SUMMARY WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT WAS REVISED DUE TO TIGHT KNEE, PATIENT WAS HAVING TROUBLE STRAIGHTENING THEIR LEG. DURING THE SURGERY, SURGEON CHOSE TO USE SMITH AND NEPHEW GEN II PATELLA WITH TRIATHLON KNEE EVEN THOUGH WAS TOLD THIS WAS NOT RECOMMENDED AND OFF LABEL. TRIATHLON AND DURACON PATELLAS WERE OFFERED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT WAS REVISED DUE TO TIGHT KNEE, PATIENT WAS HAVING TROUBLE STRAIGHTENING THEIR LEG. DURING THE SURGERY, SURGEON CHOSE TO USE SMITH AND NEPHEW GEN II PATELLA WITH TRIATHLON KNEE EVEN THOUGH WAS TOLD THIS WAS NOT RECOMMENDED AND OFF LABEL. TRIATHLON AND DURACON PATELLAS WERE OFFERED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    357687 X3 TRIATHLON CS INSERT #5 19MM IMPLANT JWH STRYKER ORTHOPAEDICS-MAHWAH LCG487

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Required Intervention