BEUDAMED
    FDA Adverse Event Injury Summary report: N

    X3 TRIATHLON CS INS SIZE4 11MM

    MDR report key: 3083093 · Received April 29, 2013

    Report

    Report Number
    0002249697-2013-01472
    Event Type
    Injury
    Date Received
    April 29, 2013
    Date of Event
    April 8, 2013
    Report Date
    April 8, 2013
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    JWH
    PMA / PMN Number
    K063423
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    AN EVENT REGARDING INSTABILITY AND PATELLAR DISLOCATION INVOLVING A TRIATHLON INSERT WAS REPORTED. THE EVENT WAS NOT CONFIRMED. IMAGES OF THE EXPLANTED DEVICES WERE PROVIDED. A PROXIMAL VIEW OF THE TIBIAL INSERT SHOWED THIRD BODY INDENTATIONS ON THE ARTICULATING SURFACES. WEAR ALONG THE EDGES OF THE INSERT WERE ALSO OBSERVED. NO FURTHER INSPECTIONS WERE PERFORMED AS THE RESEARCH FACILITY RETAINED THE EXPLANTED DEVICES. DEVICE HISTORY REVIEW INDICATED THERE HAVE BEEN NO REPORTED DISCREPANCIES FOR THE REFERENCED LOT. COMPLAINT HISTORY REVIEW INDICATED THERE HAVE BEEN NO REPORTED EVENTS FOR THE LOT REFERENCED. CONCLUSIONS: THE EXACT CAUSE OF THE EVENT COULD NOT BE DETERMINED BECAUSE FURTHER INFORMATION SUCH AS PRE- AND POST-OPERATIVE X-RAYS AND THE PRIMARY OPERATIVE REPORT AS WELL AS FOLLOW-UP NOTES ARE NEEDED TO COMPLETE THE INVESTIGATION FOR DETERMINING ROOT CAUSE.

    Description of Event or Problem · 1

    THE ARTHROPLASTY WAS REVISED DUE TO CHRONIC PATELLAR DISLOCATION, INSTABILITY AND PAIN. THE COMPONENTS WERE IMPLANTED IN SITU FOR ~3.8 Y. THE TIBIAL INSERT AND FEMORAL COMPONENTS WERE REVISED. THE PATIENT PRESENTED WITH A (B)(4) SCORE OF 3 THREE MONTHS PRIOR TO REVISION SURGERY AND A MAXIMUM SCORE OF 8.

    Description of Event or Problem · 1

    THE ARTHROPLASTY WAS REVISED DUE TO CHRONIC PATELLAR DISLOCATION, INSTABILITY AND PAIN. THE COMPONENTS WERE IMPLANTED IN SITU FOR ~3.8 Y. THE TIBIAL INSERT AND FEMORAL COMPONENTS WERE REVISED. THE PATIENT PRESENTED WITH A UCLA SCORE OF 3 THREE MONTHS PRIOR TO REVISION SURGERY AND A MAXIMUM SCORE OF 8.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    184438 X3 TRIATHLON CS INS SIZE4 11MM IMPLANT JWH STRYKER ORTHOPAEDICS-MAHWAH LBC906

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Required Intervention