BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRIATHLON ASYMMETRIC X3 PATELLA

    MDR report key: 2190437 · Received July 28, 2011

    Report

    Report Number
    2249697-2011-01137
    Event Type
    Injury
    Date Received
    July 28, 2011
    Date of Event
    July 18, 2011
    Report Date
    July 18, 2011
    Manufacturer
    STRYKER ORTHOPAEDICS MAHWAH
    Product Code
    JWH
    PMA / PMN Number
    K051146
    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 PATIENT AND 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 A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT: "PATIENT HAD KNEE REPLACEMENT 3 YEARS AGO AND HAS COMPLAINED OF PAIN SINCE REPLACEMENT. X-RAY REVEALED OSTEOPHYTE ON PATELLA. UPON EXAMINATION OF PATELLA, LOOSENING WAS IDENTIFIED. REPLACED PATELLA AND POLY INSERT. VERY GOOD POLY INTEGRITY OF IMPLANTS REMOVED. NO FURTHER PATIENT INFORMATION AVAILABLE DUE TO HOSPITAL CONFIDENTIALITY POLICY."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRIATHLON ASYMMETRIC X3 PATELLA IMPLANT JWH STRYKER ORTHOPAEDICS MAHWAH NA 776L

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Required Intervention