BEUDAMED
    FDA Adverse Event Injury Summary report: N

    X3 TRIATHLON CS INS SIZE5 13MM

    MDR report key: 13618857 · Received February 28, 2022

    Report

    Report Number
    0002249697-2022-00294
    Event Type
    Injury
    Date Received
    February 28, 2022
    Date of Event
    May 19, 2021
    Report Date
    February 28, 2022
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    MBH
    UDI-DI
    07613327336719
    PMA / PMN Number
    K172634
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    IT WAS NOTED THAT THE DEVICE IS NOT AVAILABLE FOR EVALUATION. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, IT WILL BE PROVIDED IN A SUPPLEMENTAL REPORT UPON COMPLETION OF THE INVESTIGATION. REVIEW OF THE DEVICE HISTORY RECORDS INDICATE DEVICES WERE MANUFACTURED AND ACCEPTED INTO FINAL STOCK WITH NO RELEVANT REPORTED DISCREPANCIES. THERE HAS BEEN 1 SIMILAR EVENT FOR THE LOT REFERENCED. THE FOLLOWING DEVICES WERE ALSO LISTED IN THIS REPORT: TRI TS FEMUR SZ5 RIGHT; CAT#5512-F-502 ; LOT#GGB9E. TRI TS BASEPLATE SIZE 5; CAT#5521-B-500 ; LOT#GGS4GA. TRIATHLONCTRFEMCONEAUG SZ 7&8R; CAT#5549-A-672 ; LOT# L70M1. TRIATHLON SYM CONE AUG SZ E; CAT#5549-A-150 ; LOT#HHP8. TRI CEMENTED STEM 12MMX100MM; CAT#5560-S-212 ; LOT#0090874J. TRI POST AUGMENT SZ5 5MM; CAT#5543-A-500 ; LOT# ERY7E. TRIATHLON FEMORAL DISTAL AUGMENT 5MM - SIZE 5 RIGHT; CAT#5540-A-502 ; LOT#DZO7E. TRI LM/RL TIB AUG SZ5 10MM; CAT#5546-A-501 ; LOT# ERFCA3D. TRIATHLON CEMENTED STEM-15MM X 100MM; CAT#5560-S-215 ; LOT#0077017A. TRI RM/LL TIB AUG SZ5 10MM; CAT#5546-A-502 ; LOT#ERFFM5D. TRIATHLON SYMMETRIC X3 PATELLA; CAT#5550-G-339-E ; LOT#TY1P. IT CANNOT BE DETERMINED WHICH, IF ANY OF THESE DEVICES MAY HAVE CAUSED OR CONTRIBUTED TO THE PATIENT'S EXPERIENCE.

    Description of Event or Problem · 0

    PATIENT HAD BILATERAL INDEX TKA. PATIENT IS ADMITTED WITH PAIN AND BILATERAL KNEE PJI. UNDERGOES BILATERAL REVISION ON (B)(6) 2021 WITH ALL COMPONENTS EXCHANGED, AND ANTIBIOTIC LOADED CEMENT FOR TREATMENT. PATIENT RETURNS FOR PERSISTENT RIGHT KNEE PJI ON (B)(6) 2021FOR AN I&D AND POLY EXCHANGE REPORTED. PATIENT RETURNS WITH PERSISTENT PJI, UNDERGOES NEW REVISION WITH AN I&D AND A POLY EXCHANGE ONLY. PATIENT RETURNS WITH PERSISTENT PJI, UNDERGOES ANOTHER REVISION WITH AN I&D AND A POLY EXCHANGE ONLY. PATIENT RETURNS WITH PERSISTENT PJI AND IS REVISED ON (B)(6) 2021. ALL COMPONENTS WERE EXCHANGED EXCEPT PATELLA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1147675 X3 TRIATHLON CS INS SIZE5 13MM PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO MBH STRYKER ORTHOPAEDICS-MAHWAH 5531-G-513-E H369L5 07613327336719

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Female Required Intervention| H