BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MRHK TIB INS 10MM XS/S S1/S2

    MDR report key: 23744422 · Received December 8, 2025

    Report

    Report Number
    0002249697-2025-01425
    Event Type
    Injury
    Date Received
    December 8, 2025
    Date of Event
    November 12, 2025
    Report Date
    December 8, 2025
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    KRO
    UDI-DI
    07613327043785
    PMA / PMN Number
    K994207
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    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: DEVICE NAME# MRHK BUMPER INSERT - NEUTRAL; CAT# 64812130; LOT# LMS391 DEVICE NAME# MRH AXLE; CAT# 64812120; LOT# CTD121098 DEVICE NAME# MRHK FEMORAL BUSHING; CAT# 64812110; LOT# LNF609 DEVICE NAME# MRH TIB ROT COMP XS-XL; CAT#64812100; LOT# 211581A DEVICE NAME# MRHK FEMORAL BUSHING; CAT# 64812110; LOT# LNF594 DEVICE NAME# MRHK TIBIAL SLEEVE; CAT# 64812140; LOT# LNA103 DEVICE NAME# KMAX STEM EXTNR(S,M,L,XL)155MM; CAT# 64768270; LOT# CTD135111 DEVICE NAME# MRH TIBIAL B/PLT KEEL SML 1; CAT# 64813110; LOT# T3Y7P DEVICE NAME# TRIATHLON ASYMMETRIC X3 PATELLA; CAT# 5551-G-299-E; LOT# 1HW5 DEVICE NAME# KMAX STEM EXTNR(S,M,L,XL)155MM; CAT# 64768270; LOT# CTD72102 DEVICE NAME# MRH KNEE FEM M RGT; CAT# 64811121; LOT# YPR4D 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

    REVISION OF BEARINGS COMPONENT OF MRH DUE TO INFECTION. DAIR PROCEDURE. DAIR DUE TO INFECTION ONLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2447752 MRHK TIB INS 10MM XS/S S1/S2 PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER KRO STRYKER ORTHOPAEDICS-MAHWAH LMX871 07613327043785

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Hospitalization| R