BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MRHK TIB INS 13MM XS/S S1/S2

    MDR report key: 23836083 · Received December 18, 2025

    Report

    Report Number
    0002249697-2025-01494
    Event Type
    Injury
    Date Received
    December 18, 2025
    Date of Event
    September 10, 2024
    Report Date
    May 14, 2026
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    KRO
    UDI-DI
    07613327043792
    PMA / PMN Number
    K223069
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    REVIEW OF THE DEVICE HISTORY RECORDS INDICATE THAT DEVICES WERE MANUFACTURED AND ACCEPTED INTO FINAL STOCK WITH NO REPORTED DISCREPANCIES. THERE HAVE BEEN NO OTHER EVENTS FOR THE LOT REFERENCED. 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: MRH AXLE; CAT# 64812120; LOT# CTD39651, MRHK FEMORAL BUSHING; CAT#64812110; LOT# LKN222, MRHK TIBIAL SLEEVE; CAT# 64812140; LOT# LKP069, MRHK BUMPER INSERT 3 DEGREES; CAT# 64812133; LOT# LKY364, MRH TIB ROT COMP XS-XL; CAT# 64812100; LOT# 180645, MRHK FEMORAL BUSHING; CAT# 64812110; LOT# LKR198, MRH KNEE FEM XS LFT; CAT# 64811100; LOT# JHA6B, MRH TIBIAL B/PLT KEEL SML 1; CAT# 64813110; LOT# L6H6T, TRIATHLON SYM CONE AUG SZ C; CAT#5549-A-130; LOT# T1J51, TRI PRESS-FIT STEM 14MM X 100MM; CAT# 5565-S-014; LOT# 0113782K, TRI PRESS-FIT STEM 16X150MM; CAT# 5566-S-016; LOT# 0087321D, TRIATHLONCTRFEMCONEAUG SZ1&2L; CAT#5549-A-621; LOT# LH641, MRHK FEM DISTAL BLK 10MM XSE; CAT# 64811200; LOT# UNKNOWN, MRHK FEM DISTAL BLK 10MM XS; CAT# 64811200; LOT# UNKNOWN. 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

    THE FOLLOWING INFORMATION WAS PROVIDED: THE PATIENT HAD AN INDEX LEFT TKA OUTSIDE OF CORS SCOPE. THE PATIENT DEVELOPED PJI IN THE LEFT KNEE AND UNDERWENT REVISION WITH A GMRS SYSTEM FOR PJI. ALL COMPONENTS EXCHANGED ON (B)(6) 2021 (THEN INCLUDED INTO CORS). THE PATIENT DEVELOPED AGAIN PJI AND WAS REVISED ONLY FOR ALL ROTATING HINGE COMPONENTS EXCHANGED ON (B)(6) 2021. PATIENT DEVELOPED AGAIN PJI AND IS REVISED ON (B)(6) 2024. ONLY ALL ROTATING HINGE COMPONENTS WERE EXCHANGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    185959 MRHK TIB INS 13MM XS/S S1/S2 PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER KRO STRYKER ORTHOPAEDICS-MAHWAH LKP931 07613327043792

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Female Hospitalization| R