BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MRHK TIB INS 10MM XS/S S1/S2

    MDR report key: 24055187 · Received January 13, 2026

    Report

    Report Number
    0002249697-2026-00019
    Event Type
    Injury
    Date Received
    January 13, 2026
    Date of Event
    December 17, 2025
    Report Date
    January 13, 2026
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    KRO
    UDI-DI
    07613327043785
    PMA / PMN Number
    K223069
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING DEVICES WERE ALSO LISTED IN THIS REPORT: CAT#; DEVICE NAME; LOT# 64811100; MRH KNEE FEM XS LFT, JNJ4L; 64768260; KMAX STEM EXTNR(S,M,L,XL),80MM;LCP0090; 64812130;MRHK BUMPER INSERT - NEUTRAL;LMN037; 64812110;MRHK FEMORAL BUSHING;LLA543; 64812110;MRHK FEMORAL BUSHING;LLC980; 64812120;MRH AXLE;CTD97282; 64811200;MRHK FEM DISTAL BLK 10MM XS;LP77S; 6215-5-011;MED HOWMEDICA BONE PLUG 1PK;CPPABG10BC; 64812140;MRHK TIBIAL SLEEVE;LLF406; 64768260;KMAX STEM EXTNR(S,M,L,XL),80MM;LCP0094; 64812100;MRH TIB ROT COMP XS-XL;2115549A; 6215-5-001;SMALL HOWMEDICA BONE PLUG 1PK;CPPABG05BD; 64813110;MRH TIBIAL B/PLT KEEL SML 1;YJ43J. IT CANNOT BE DETERMINED WHICH, IF ANY OF THESE DEVICES MAY HAVE CAUSED OR CONTRIBUTED TO THE PATIENT'S EXPERIENCE. 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.

    Description of Event or Problem · 0

    THE FOLLOWING INFORMATION WAS PROVIDED: REVISION OF LEFT MRH, 2 STAGE, DUE TO LIKELY INFECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    118284 MRHK TIB INS 10MM XS/S S1/S2 PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER KRO STRYKER ORTHOPAEDICS-MAHWAH LMR266 07613327043785

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Female Hospitalization| R