BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRIATHLON PKR BASEPLATE #2 RM/LL

    MDR report key: 2170054 · Received July 13, 2011

    Report

    Report Number
    2249697-2011-01047
    Event Type
    Injury
    Date Received
    July 13, 2011
    Date of Event
    June 20, 2011
    Report Date
    June 20, 2011
    Manufacturer
    STRYKER ORTHOPAEDICS MAHWAH
    Product Code
    HRY
    PMA / PMN Number
    K071881
    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 NOT RETURNED TO THE MANUFACTURER. ADDITIONAL INFORMATION (INCLUDING X-RAYS AND MEDICAL RECORDS) WAS REQUESTED. SHOULD DEVICE OR ADDITIONAL INFORMATION BECOME AVAILABLE, THE EVALUATION SUMMARY WILL BE SUBMITTED IN THE SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT, "SURGEON COMMENTED THAT PATIENT WAS OSTEOPOROTIC AND THE TIBIA COMPONENT COLLAPSED. HE REVISED TO A PS FEMUR AND UNIVERSAL BASEPLATE WITH A 9 X 100MM STEM AND 10MM MEDIAL AUGMENT."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRIATHLON PKR BASEPLATE #2 RM/LL IMPLANT HRY STRYKER ORTHOPAEDICS MAHWAH NA ZCRZA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention