BEUDAMED
    FDA Adverse Event Injury Summary report: N

    X3 TRIATHLON CS INSERT #7 13MM

    MDR report key: 3588063 · Received January 22, 2014

    Report

    Report Number
    0002249697-2014-00172
    Event Type
    Injury
    Date Received
    January 22, 2014
    Date of Event
    January 2, 2014
    Report Date
    January 2, 2014
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    JWH
    PMA / PMN Number
    K063423
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AN EVENT REGARDING INSTABILITY INVOLVING A TRIATHLON INSERT WAS REPORTED. THE EVENT WAS NOT CONFIRMED. 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. 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 PATIENT HISTORY AND FOLLOW-UP NOTES ARE NEEDED TO COMPLETE THE INVESTIGATION FOR DETERMINING ROOT CAUSE.

    Additional Manufacturer Narrative · 1

    IT WAS NOTED THAT THE DEVICE IS NOT AVAILABLE FOR EVALUATION DUE TO HOSPITAL POLICY. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IF RECEIVED, WILL BE PROVIDED IN THE SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT FELL AND SUSTAINED LIGAMENT INSTABILITY SO THE SURGEON REVISED THE RIGHT KNEE. NO X-RAYS OR MEDICAL RECORDS WILL BE MADE AVAIL AS PER HOSPITAL PROTOCOL.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT FELL AND SUSTAINED LIGAMENT INSTABILITY SO THE SURGEON REVISED THE RIGHT KNEE. NO X-RAYS OR MEDICAL RECORDS WILL BE MADE AVAIL AS PER HOSPITAL PROTOCOL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    51966 X3 TRIATHLON CS INSERT #7 13MM IMPLANT JWH STRYKER ORTHOPAEDICS-MAHWAH LDB828

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Required Intervention