BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK TRIATHLON # 7 BASEPLATE

    MDR report key: 1908306 · Received November 17, 2010

    Report

    Report Number
    2249697-2010-01566
    Event Type
    Injury
    Date Received
    November 17, 2010
    Date of Event
    October 26, 2010
    Report Date
    October 27, 2010
    Manufacturer
    STRYKER ORTHOPAEDICS MAHWAH
    Product Code
    JWH
    PMA / PMN Number
    UNK
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AN EVALUATION OF THE DEVICE CANNOT BE PERFORMED AS THE DEVICE WAS RETAINED BY THE HOSPITAL AND NOT RETURNED TO THE MANUFACTURER. ADDITIONAL INFORMATION INCLUDING X-RAYS AND MEDICAL RECORDS WAS REQUESTED. IF IT BECOMES AVAILABLE, THE EVALUATION SUMMARY WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT, "DR PERFORMED A REVISION ON A LEFT TOTAL KNEE (STRYKER TRIATHLON SIZE 7PS, SIZE 7 BASEPLATE, SIZE 11MM POLY X 3, 38 PATELLA INITIALLY AND REVISED WITH A UNIVERSAL BASEPLATE WITH 16MM POLY AND 15/50MM STEM CEMENTED WITH SIMPLEX P WITH TOBRA). TIBIAL COMPONENT LOOKED LOOSE VIA BONE SCAN. STABILITY WAS GOOD. PROCEDURE PERFORMED PERFECTLY WITH NO ADVERSE CONSEQUENCES."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNK TRIATHLON # 7 BASEPLATE IMPLANT JWH STRYKER ORTHOPAEDICS MAHWAH NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Required Intervention