BEUDAMED
    FDA Adverse Event Injury Summary report: N

    X3 TRIATHLON CS INS SIZE 4 9MM

    MDR report key: 3111524 · Received May 14, 2013

    Report

    Report Number
    0002249697-2013-01665
    Event Type
    Injury
    Date Received
    May 14, 2013
    Date of Event
    April 23, 2013
    Report Date
    April 23, 2013
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    JWH
    PMA / PMN Number
    K063423
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    WHEN COMPLETED, THE EVALUATION SUMMARY WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.

    Additional Manufacturer Narrative · 1

    AN EVENT REGARDING INSTABILITY INVOLVING A TRIATHLON INSERT WAS REPORTED. THE EVENT WAS NOT CONFIRMED. VISUAL INSPECTION INDICATED THE TRIATHLON CS INSERT SHOWED SIGNS OF EXPLANTATION DAMAGE DEFINED BY SCRATCHES AND INDENTATIONS ON THE ANTERIOR, INTERIOR AND BEARING SURFACES. THE LOCKING WIRE IS OBSERVED TO BE ABSENT. THIRD BODY WEAR ON THE BEARING SURFACE WAS ALSO OBSERVED. MEDICAL RECORDS EVALUATION NOT PERFORMED AS NO MEDICAL RECORDS WERE PROVIDED. THERE HAVE BEEN NO REPORTED DISCREPANCIES FOR THE REFERENCED LOT. THERE HAVE BEEN NO REPORTED EVENTS FOR THE LOT REFERENCED. THE EXACT CAUSE OF THE EVENT COULD NOT BE DETERMINED BECAUSE FURTHER INFORMATION IS NEEDED. NO FURTHER INVESTIGATION FOR THIS EVENT IS POSSIBLE AT THIS TIME.

    Description of Event or Problem · 1

    PATIENT AT 6 MONTHS FOLLOW UP FELT HER KNEE SEEMED LOOSE AND UNSTABLE. WAITED ONE YEAR AND HAD REVISION SURGERY A 9MM CS WAS REMOVED AND A 13MM CS INSERT WAS PLACED.

    Description of Event or Problem · 1

    PATIENT AT 6 MONTHS FOLLOW UP FELT HER KNEE SEEMED LOOSE AND UNSTABLE. WAITED ONE YEAR AND HAD REVISION SURGERY A 9MM CS WAS REMOVED AND A 13MM CS INSERT WAS PLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    213052 X3 TRIATHLON CS INS SIZE 4 9MM IMPLANT JWH STRYKER ORTHOPAEDICS-MAHWAH LCU005

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Required Intervention