BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRIATHLON SYMMETRIC X3 PATELLA

    MDR report key: 3927324 · Received July 10, 2014

    Report

    Report Number
    0002249697-2014-02644
    Event Type
    Injury
    Date Received
    July 10, 2014
    Date of Event
    October 22, 2013
    Report Date
    June 17, 2014
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    JWH
    PMA / PMN Number
    K051146
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CATALOG NUMBER UNKNOWN AT THIS TIME. DEVICE DESCRIPTION REPORTED AS UNKNOWN STRYKER TRIATHALON LEFT KNEE. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IF RECEIVED WILL BE SUBMITTED IN A FOLLOW UP REPORT UPON COMPLETION OF THE INVESTIGATION. DEVICE REMAINS IMPLANTED.

    Additional Manufacturer Narrative · 1

    THE PATIENT IS (B)(6) IN HEIGHT. AN EVENT REGARDING PATELLA CLUNK SYNDROME INVOLVING A TRIATHLON PATELLA WAS REPORTED. CONCLUSION THE PROVIDED RECORDS INDICATE THE SUBJECT TRIATHLON PATELLA WAS USED IN CONJUNCTION WITH A COMPETITOR FEMORAL COMPONENT IN THE PATIENT'S PATELLOFEMORAL ARTHROPLASTY. REVIEW OF THE IFU PACKED WITH THE PATELLA COMPONENT INDICATED: "HOWMEDICA OSTEONICS CORP. 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.

    Description of Event or Problem · 1

    UPDATE AS PER PATIENT: PATIENT IS SCHEDULED TO HAVE A REVISION SURGERY ON (B)(6) 2014.

    Description of Event or Problem · 1

    HUSBAND REPORTS HIS WIFE'S KNEE CAP POPS AND IS EXPERIENCING SOME PAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    403112 TRIATHLON SYMMETRIC X3 PATELLA IMPLANT JWH STRYKER ORTHOPAEDICS-MAHWAH 02P8

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Other