BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN TIBIAL BASEPLATE - MRH KNEE

    MDR report key: 23367313 · Received October 23, 2025

    Report

    Report Number
    0002249697-2025-01174
    Event Type
    Injury
    Date Received
    October 23, 2025
    Date of Event
    June 11, 2024
    Report Date
    November 25, 2025
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    KRO
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    AN EVENT REGARDING LOOSENING INVOLVING AN UNKNOWN MRH TIBIAL COMPONENT. THE EVENT WAS CONFIRMED VIA REVIEW OF PROVIDED MEDICAL RECORDS BY A CLINICIAN. METHOD & RESULTS: -PRODUCT EVALUATION AND RESULTS: MATERIAL ANALYSIS, VISUAL, FUNCTIONAL, AND DIMENSIONAL INSPECTIONS COULD NOT BE PERFORMED AS THE DEVICE WAS NOT RETURNED. -CLINICIAN REVIEW: A REVIEW OF MEDICAL RECORDS WITH A CLINICAL CONSULTANT INDICATED: 'I HAVE REVIEWED THE DOCUMENTATION PROVIDED INCLUDING THE PRODUCT INQUIRY COVER SHEET, AND AN AP AND TWO LATERAL X-RAYS X-RAY OF A RIGHT HINGED TKA . EVENT DESCRIPTION: AS PER PSS IMPLANT REQUEST: FAILED RIGHT COMPLEX TOTAL KNEE ARTHROPLASTY WITH STANDARD MODULAR ROTATING HINGED KNEE. TIBIAL COMPONENT HAS FAILED AND LOOSENED. THE X-RAYS SHOWED THE CEMENTED IMPLANTS IN ANATOMIC POSITION. THERE ARE SIGNIFICANT LUCENCIES SURROUNDING THE TIBIAL STEM CONSISTENT WITH LOSS OF FIXATION AND FAILURE. LOSS OF FIXATION AND FAILURE OF THE TIBIAL COMPONENT IN MODULAR ROTATING HINGED TKA IS CONFIRMED. THE ROOT CAUSE OF THIS LOSS OF FIXATION AND FAILURE OF THE TIBIAL COMPONENT IN MODULAR ROTATING HINGED TKA CANNOT BE DETERMINED FROM THE LIMITED INFORMATION PROVIDED." -PRODUCT HISTORY REVIEW: COULD NOT BE PERFORMED AS THE DEVICE LOT DETAILS WERE NOT PROVIDED. -COMPLAINT HISTORY REVIEW: COULD NOT BE PERFORMED AS THE DEVICE LOT DETAILS WERE NOT PROVIDED. CONCLUSIONS: A REVIEW OF THE PROVIDED MEDICAL RECORDS BY A CLINICAL CONSULTANT INDICATED: A REVIEW OF MEDICAL RECORDS WITH A CLINICAL CONSULTANT INDICATED "THE X-RAYS SHOWED THE CEMENTED IMPLANTS IN ANATOMIC POSITION. THERE ARE SIGNIFICANT LUCENCIES SURROUNDING THE TIBIAL STEM CONSISTENT WITH LOSS OF FIXATION AND FAILURE. LOSS OF FIXATION AND FAILURE OF THE TIBIAL COMPONENT IN MODULAR ROTATING HINGED TKA IS CONFIRMED. THE ROOT CAUSE OF THIS LOSS OF FIXATION AND FAILURE OF THE TIBIAL COMPONENT IN MODULAR ROTATING HINGED TKA CANNOT BE DETERMINED FROM THE LIMITED INFORMATION PROVIDED.".

    Description of Event or Problem · 0

    THE FOLLOWING INFORMATION WAS PROVIDED: AS PER PSS IMPLANT REQUEST CASE 100569: FAILED RIGHT COMPLEX TOTAL KNEE ARTHROPLASTY WITH STANDARD MODULAR ROTATING HINGED KNEE. TIBIAL COMPONENT HAS FAILED AND LOOSENED.

    Description of Event or Problem · 0

    NO NEW INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2739914 UNKNOWN TIBIAL BASEPLATE - MRH KNEE PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER KRO STRYKER ORTHOPAEDICS-MAHWAH UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Female Other