BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NO 6. TRIATHLON TS PLUS TIBIAL INSERT X3 POLY 22MM

    MDR report key: 7491240 · Received May 7, 2018

    Report

    Report Number
    0002249697-2018-01341
    Event Type
    Injury
    Date Received
    May 7, 2018
    Date of Event
    April 9, 2018
    Report Date
    May 7, 2018
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    MBH
    PMA / PMN Number
    K141056
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GB
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    REVIEW OF THE DEVICE HISTORY RECORDS INDICATE THAT DEVICES WERE MANUFACTURED AND ACCEPTED INTO FINAL STOCK ON 21 MAY 2014 WITH NO RELEVANT REPORTED DISCREPANCIES. THERE HAVE BEEN NO OTHER EVENTS FOR THE LOT REFERENCED. IT WAS NOTED THAT THE DEVICE IS NOT AVAILABLE FOR EVALUATION. IF ADDITIONAL INFORMATION IS RECEIVED, IT WILL BE PROVIDED IN A SUPPLEMENTAL REPORT UPON COMPLETION OF THE INVESTIGATION. THE FOLLOWING DEVICES WERE ALSO LISTED IN THIS REPORT: TRI TS FEMUR SZ6 RIGHT, CAT#5512-F-602 INKU. TRI PRESS-FIT STEM 19MM X 100MM; CAT#5565-S-019; LOT#M9H46H. TRIATHLON TOTAL KNEE SYSTEM OFFSET ADAPTER 4MM; CAT#5570-S-040; LOT#M9E7K. SIMPLEX ABC CE MARK 1 PCK; CAT#61969001; LOT#BCW011. SIMPLEX ABC CE MARK 1 PCK; CAT#61969001; LOT#BKV037. TRI TS BASEPLATE SIZE 6; CAT#5521-B-600; LOT#MIYN. TRIATHLON TOTAL KNEE SYSTEM OFFSET ADAPTER 8MM; CAT#5570-S-080; LOT#M3W41AH. TRI PRESS-FIT STEM 15MM X 100MM; CAT#5565-S-015; LOT#M8T19L. TRIATHLON ASYM PATELLA A38X11; CAT#5551L381; LOT#LDJ833. IT CANNOT BE DETERMINED WHICH, IF ANY OF THESE DEVICES MAY HAVE CAUSED OR CONTRIBUTED TO THE PATIENT'S EXPERIENCE. DEVICE NOT AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT SURGEON WILL PERFORM A SECOND REVISION ON A PATIENT'S KNEE REPLACEMENT DUE TO A SUSPECTED INFECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    335012 NO 6. TRIATHLON TS PLUS TIBIAL INSERT X3 POLY 22MM PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO MBH STRYKER ORTHOPAEDICS-MAHWAH MMHH8J

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Other