BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MRHK TIB INS 13MM M/L M2/L2

    MDR report key: 25019310 · Received April 28, 2026

    Report

    Report Number
    0002249697-2026-00346
    Event Type
    Injury
    Date Received
    April 28, 2026
    Date of Event
    October 1, 2025
    Report Date
    May 22, 2026
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    KRO
    UDI-DI
    07613327043846
    PMA / PMN Number
    K223069
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    AN EVENT REGARDING INFECTION INVOLVING A MRH INSERT WAS REPORTED. THE EVENT WAS NOT CONFIRMED. METHOD & RESULTS: -DEVICE EVALUATION AND RESULTS: NOT PERFORMED AS PRODUCT WAS NOT RETURNED. -CLINICIAN REVIEW: NO MEDICAL RECORDS WERE RECEIVED FOR REVIEW WITH A CLINICAL CONSULTANT. -DEVICE HISTORY REVIEW: ALL DEVICES WERE MANUFACTURED AND ACCEPTED INTO FINAL STOCK WITH NO RELEVANT REPORTED DISCREPANCIES. -COMPLAINT HISTORY REVIEW: THERE HAVE BEEN NO OTHER SIMILAR EVENTS FOR THE LOT AND STERILE LOT REFERENCED. CONCLUSIONS: IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO INFECTION. ALL STRYKER PRODUCTS ARE SOLD AS STERILE EITHER BY BEING VALIDATED TO A MINIMUM STERILITY ASSURANCE LEVEL SAL OF 10^-6 OR ASEPTICALLY FILLED UNDER A VALIDATED PROCESS IN ACCORDANCE WITH APPLICABLE EXTERNAL STANDARDS. THE EXACT CAUSE OF THE EVENT COULD NOT BE DETERMINED BECAUSE INSUFFICIENT INFORMATION WAS PROVIDED. ADDITIONAL INFORMATION INCLUDING PATHOLOGY REPORTS, OPERATIVE REPORTS, PROGRESS NOTES, X-RAYS AND RETURN OF THE DEVICE ARE NEEDED TO FULLY INVESTIGATE THE EVENT. IF FURTHER INFORMATION BECOMES AVAILABLE OR THE PRODUCT IS RETURNED, THIS INVESTIGATION WILL BE RE-OPENED. THE FOLLOWING DEVICES WERE ALSO LISTED IN THIS REPORT: 64952010 GMRS DIST FEM COMP SML L 65MM 6AP9L, 64952105 GMRS SMALL FEMORAL BUSHING LNY066, 64952105 GMRS SMALL FEMORAL BUSHING LNY066, 64952115 GMRS SMALL AXLE CTD159658A, 6704-0-520 D-M 2.0MM BEADED CABLE SET VIT 290084951, 6495-5-219 19MM PRESS FIT BOWED STEM 150 230801C, 64812100 MRH TIB ROT COMP XS-XL 211530, 64956030 GMRS EXTENSION PIECE 30MM 4RRRU, 64812130 MRHK BUMPER INSERT - NEUTRAL LME005, 64812140 MRHK TIBIAL SLEEVE LMT164. UNKNOWN MRH TIBIAL BASEPLATE. UNKNOWN MRH STEM (TIBIAL). 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

    IT WAS REPORTED THAT THE PATIENT'S LEFT DISTAL FEMORAL REPLACEMENT WAS REVISED DUE TO INFECTION. FEMORAL IMPLANTS WERE REMOVED AND A SPACER WAS PLACED AS A FIRST STAGE REVISION. REP CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    173229 MRHK TIB INS 13MM M/L M2/L2 PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER KRO STRYKER ORTHOPAEDICS-MAHWAH LMF524 07613327043846

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Male Required Intervention| H