BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MRH TIBIAL B/PLT KEEL SML 1

    MDR report key: 22726909 · Received August 6, 2025

    Report

    Report Number
    0002249697-2025-00833
    Event Type
    Injury
    Date Received
    August 6, 2025
    Date of Event
    August 1, 2016
    Report Date
    August 6, 2025
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    KRO
    UDI-DI
    07613327045307
    PMA / PMN Number
    K002552
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    AN EVALUATION OF THE DEVICE CANNOT BE PERFORMED AS THE DEVICE WAS NOT RETURNED TO THE MANUFACTURER. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE IT WILL BE REPORTED IN A SUPPLEMENTAL REPORT UPON COMPLETION OF THE INVESTIGATION. THE FOLLOWING DEVICES WERE ALSO LISTED IN THIS REPORT: CAT# 64786630; TI DUR REG FLUTED STEM 16X80MM; LOT# UNKNOWN. CAT# 64811101; MRH KNEE FEM XS RHT; LOT# UNKNOWN. CAT# 64786710; TI DUR REG FLUTED STEM15X155MM; 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

    INFORMATION RECEIVED FROM (B)(4) INDICATES THE FOLLOWING: NONUNION OF IMPLANT PROXIMALLY AND DISTAL TIBIA FRACTURE W/ MALUNION/NON-UNION. R ABOVE KNEE AMPUTATION PERFORMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1364893 MRH TIBIAL B/PLT KEEL SML 1 PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER KRO STRYKER ORTHOPAEDICS-MAHWAH UNKNOWN 07613327045307

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Required Intervention| H