BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRIATHLON ASYMMETRIC X3 PATELLA

    MDR report key: 1951879 · Received December 29, 2010

    Report

    Report Number
    2249697-2010-01915
    Event Type
    Injury
    Date Received
    December 29, 2010
    Date of Event
    December 6, 2010
    Report Date
    December 6, 2010
    Manufacturer
    STRYKER ORTHOPAEDICS MAHWAH
    Product Code
    JWH
    PMA / PMN Number
    K051146
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, 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 AT THIS TIME. ADDITIONAL INFORMATION (INCLUDING X-RAYS AND MEDICAL RECORDS) WAS REQUESTED. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THE EVALUATION SUMMARY WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT, "PATELLA APPEARED TO BE SHEARED OFF."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRIATHLON ASYMMETRIC X3 PATELLA IMPLANT JWH STRYKER ORTHOPAEDICS MAHWAH NA 742F

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Other| R