BEUDAMED
    FDA Adverse Event Other Summary report: N

    TRIATHLON FEMORAL DISTAL AUGMENT 5MM - SIZE 5 RIGH

    MDR report key: 1289475 · Received January 13, 2009

    Report

    Report Number
    2249697-2009-00024
    Event Type
    Other
    Date Received
    January 13, 2009
    Date of Event
    December 18, 2008
    Report Date
    December 19, 2008
    Manufacturer
    STRYKER ORTHOPAEDICS MAHWAH
    Product Code
    JWH
    PMA / PMN Number
    K070095
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION IS IN PROGRESS. NO ADDITIONAL INFORMATION AVAILABLE AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT "THE PATIENT HAD A LARGE DISTAL AND POSTERIOR DEFICIT ON THE LATERAL SIDE OF THE RIGHT KNEE AFTER THE PRIMARY IMPLANT WAS REMOVED. AFTER MULTIPLE ATTEMPTS TRIALING ALL DIFFERENT OPTIONS, THE ONLY VIABLE OPTION FOR THE SURGEON WAS TO CEMENT ON A 5MM POSTERIOR AUGMENT ON TOP OF THE 15MM AUGMENT. THE 15MM AUGMENT WAS SCREWED ON THE FEMORAL COMPONENT, ON THE LATERAL SIDE, AND THE 5MM DISTAL AUGMENT WAS CEMENTED ON TOP AND COMPLETELY DRIED BEFORE CEMENTING THE TS FEMUR ON THE PATIENT." THIS IS NOT A REPORT OF A DEVICE MALFUNCTION, BUT THIS USE IS NOT RECOMMENDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRIATHLON FEMORAL DISTAL AUGMENT 5MM - SIZE 5 RIGH IMPLANT JWH STRYKER ORTHOPAEDICS MAHWAH NA XXLK

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Other