BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRIATHLON #5 CR INSERT 11MM

    MDR report key: 3051323 · Received April 10, 2013

    Report

    Report Number
    0002249697-2013-01236
    Event Type
    Injury
    Date Received
    April 10, 2013
    Date of Event
    March 18, 2013
    Report Date
    March 18, 2013
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    JWH
    PMA / PMN Number
    K040267
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, 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. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IF RECEIVED WILL BE PROVIDED IN A SUPPLEMENTAL REPORT. (B)(4): NOT RETURNED TO MANUFACTURER.

    Additional Manufacturer Narrative · 1

    AN EVENT REGARDING REVISION SURGERY DUE TO INSTABILITY INVOLVING A TRIATHLON INSERT WAS REPORTED. THE EVENT WAS NOT CONFIRMED. DEVICE EVALUATION NOT PERFORMED AS NO ITEMS WERE RETURNED. 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.

    Description of Event or Problem · 1

    PATIENT WAS UNSTABLE AND HAD PAIN ON LATERAL SIDE OF KNEE. SCHEDULED APPT. WITH NEW SURGEON FOR EVALUATION. REVISION WAS DONE. REMOVED AND REPLACED FEMUR AND POLY WITH TS FEMUR AND PS POLY.

    Description of Event or Problem · 1

    PATIENT WAS UNSTABLE AND HAD PAIN ON LATERAL SIDE OF KNEE. SCHEDULED APPT. WITH NEW SURGEON FOR EVALUATION. REVISION WAS DONE. REMOVED AND REPLACED FEMUR AND POLY WITH TS FEMUR AND PS POLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    152896 TRIATHLON #5 CR INSERT 11MM IMPLANT JWH STRYKER ORTHOPAEDICS-MAHWAH LBJ389

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Required Intervention