BEUDAMED
    FDA Adverse Event Injury Summary report: N

    KNEE COMPONENTS

    MDR report key: 18446546 · Received January 4, 2024

    Report

    Report Number
    1038671-2024-00020
    Event Type
    Injury
    Date Received
    January 4, 2024
    Date of Event
    December 15, 2023
    Report Date
    February 23, 2026
    Manufacturer
    EXACTECH, INC.
    Product Code
    JWH
    PMA / PMN Number
    UNK
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (H3) PENDING EVALUATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THIS 71 Y/O FEMALE PATIENT'S KNEE LEFT WAS REVISED. WHEN REVISING A CCK REVISION THAT WAS IMPLANTED IN (B)(6) 2017. THE PATIENT HAD FALLEN PREVIOUSLY AND HER PAIN HAD GOTTEN PROGRESSIVELY WORSE OVER TIME. THE PLAN WAS A TO REVISE THE TIBIAL COMPONENTS AS IT APPEARED ON XRAY THAT THEY WERE LOOSE. UPON FLEXING THE KNEE UP DURING THE REVISION IS COULD BE SEEN THAT THE CCK LOCKING SCREW THAT GOES THROUGH THE TIBIAL INSERT AND THREADS INTO THE TIBIAL STEM HAD BACKED ITSELF OUT AND WAS IN CLEAR VIEW OF THE OPERATING SURGEON. THE SCREW HAD BEEN COMING INTO CONTACT WITH THE FEMORAL COMPONENT AND HAD CAUSED THE ISSUES AFTER THE PATIENTS FALL. THERE WAS SIGNS OF METALLOSIS IS THE JOINT DUE TO THE METAL ON METAL REACTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1574092 KNEE COMPONENTS PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL JWH EXACTECH, INC. UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Female