BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XSMALL KRH ALL POLY TIBIA 11MM

    MDR report key: 22673404 · Received July 31, 2025

    Report

    Report Number
    0002249697-2025-00749
    Event Type
    Injury
    Date Received
    July 31, 2025
    Date of Event
    December 22, 2021
    Report Date
    July 31, 2025
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    JWH
    UDI-DI
    07613327047462
    PMA / PMN Number
    K972863
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    INFORMATION RECEIVED FROM IIS 2023-001 INDICATES THE FOLLOWING: I&D, INTRAMEDULLARY NAIL FOR PJI, PROSTHETIC FX. NO IMPLANTS REMOVED. LEFT KNEE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    46429 XSMALL KRH ALL POLY TIBIA 11MM PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL JWH STRYKER ORTHOPAEDICS-MAHWAH UNKNOWN 07613327047462

    Patients

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