BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRIATHLON SYMMETRIC X3 PATELLA

    MDR report key: 3010135 · Received March 19, 2013

    Report

    Report Number
    0002249697-2013-01018
    Event Type
    Injury
    Date Received
    March 19, 2013
    Date of Event
    February 14, 2011
    Report Date
    February 22, 2013
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    NPJ
    PMA / PMN Number
    K052917
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CATALOG NUMBERS AND LOT CODES OF THE OTHER DEVICES LISTED IN THE REPORT: CAT. NO.: 5520-B-300, TRIATHLON PRIM TIB BASEPLATE CEMENTED, LOT: BNDR. CAT NO.: 5510-F-301, TRIATHLON CR FEM COMP #3 L-CEM, LOT: SRMYJ. CAT NO.: 5531-G-319 X3, TRIATHLON CS INSERT #3 19MM, LOT: LBT169. CAT NO.: 6192-1-001, SIMPLEX P SPEEDSET FULL DOSE 1 PACK, LOT DLR034. AT THIS TIME, IT CANNOT BE DETERMINED WHICH, IF ANY OF THESE DEVICES MAY HAVE CAUSED OR CONTRIBUTED TO THE PATIENT'S PAIN.

    Additional Manufacturer Narrative · 1

    THE DEVICE HISTORY REVIEW INDICATES THAT ALL DEVICES WERE MANUFACTURED AND ACCEPTED INTO FINAL STOCK WITH NO REPORTED DISCREPANCIES. THE COMPLAINT HISTORY REVIEW INDICATES THERE HAVE BEEN NO OTHER EVENTS FOR THIS LOT. A REVIEW OF THE PROVIDED MEDICAL RECORDS AND X-RAYS BY A CLINICAL CONSULTANT INDICATED IT IS NOT POSSIBLE TO DETERMINE THE CAUSE OF THE COMPLAINTS NOTED IN THE EVENT DESCRIPTION BASED UPON THE DOCUMENTATION AVAILABLE FOR REVIEW. THE EVENT COULD NOT BE CONFIRMED NOR THE ROOT CAUSE DETERMINED BECAUSE THE DEVICES WERE NOT RETURNED FOR EVALUATION AND INSUFFICIENT MEDICAL INFORMATION WAS PROVIDED. IF THE DEVICES AND/OR ADDITIONAL INFORMATION ARE RECEIVED, THIS INVESTIGATION WILL BE REOPENED AND RE-EVALUATED.

    Additional Manufacturer Narrative · 1

    CATALOGUE NUMBER UNKNOWN AT THIS TIME. DEVICE DESCRIPTION REPORTED AS UNKNOWN LEFT TRIATHLON KNEE. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IF RECEIVED WILL BE PROVIDED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT IS CURRENTLY EXPERIENCING SHARP PAIN IN HER KNEE AREA. PATIENT IS ALSO COMPLAINING OF SWELLING AND HAVING PROBLEMS WITH CERTAIN MOVEMENTS. PATIENT IS CURRENTLY WALKING WITH A CANE AND ACTIVITY LEVEL IS SEDENTARY. PATIENT HAS BEEN ADVISED TO HAVE REVISION SURGERY BUT NO DATE HAS BEEN SET.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT IS CURRENTLY EXPERIENCING SHARP PAIN IN HER KNEE AREA. PATIENT IS ALSO COMPLAINING OF SWELLING AND HAVING PROBLEMS WITH CERTAIN MOVEMENTS. PATIENT IS CURRENTLY WALKING WITH A CANE AND ACTIVITY LEVEL IS SEDENTARY. PATIENT HAS BEEN ADVISED TO HAVE REVISION SURGERY BUT NO DATE HAS BEEN SET.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT IS CURRENTLY EXPERIENCING SHARP PAIN IN HER KNEE AREA. PATIENT IS ALSO COMPLAINING OF SWELLING AND HAVING PROBLEMS WITH CERTAIN MOVEMENTS. PATIENT IS CURRENTLY WALKING WITH A CANE AND ACTIVITY LEVEL IS SEDENTARY. PATIENT HAS BEEN ADVISED TO HAVE REVISION SURGERY BUT NO DATE HAS BEEN SET.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    114570 TRIATHLON SYMMETRIC X3 PATELLA IMPLANT NPJ STRYKER ORTHOPAEDICS-MAHWAH

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Other