BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MRH TIBIAL B/PLT KEEL SML 2

    MDR report key: 22673377 · Received July 31, 2025

    Report

    Report Number
    0002249697-2025-00747
    Event Type
    Injury
    Date Received
    July 31, 2025
    Date of Event
    April 22, 2015
    Report Date
    July 31, 2025
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    KRO
    UDI-DI
    07613327045314
    PMA / PMN Number
    K994207
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING DEVICES WERE ALSO LISTED IN THIS REPORT: DEVICE NAME# TI DUR REG FLUTED STEM 21X80MM; CAT# 64786655; LOT# UNKNOWN. DEVICE NAME# MRH KNEE FEM M LFT; CAT# 64811120; LOT# UNKNOWN. DEVICE NAME# TI DUR REG FLUTED STEM 18X80MM; CAT# 64786640; 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: PROSTHETIC JOINT INFECTION. INFECTION DIAGNOSED AS COAG NEGATIVE STAPH, BUT UNCLEAR IF SPACER WAS PLACED (STUDY DATA INDICATES NO COMPONENTS WERE REMOVED). LEFT KNEE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    45477 MRH TIBIAL B/PLT KEEL SML 2 PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER KRO STRYKER ORTHOPAEDICS-MAHWAH UNKNOWN 07613327045314

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Other