BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MMIS TIB KNEE ATTUNE 35MM AOX POSTERIOR STABILIZE INSERT

    MDR report key: 22458111 · Received July 9, 2025

    Report

    Report Number
    MW5172439
    Event Type
    Injury
    Date Received
    July 9, 2025
    Date of Event
    February 10, 2025
    Report Date
    July 7, 2025
    Manufacturer
    DEPUY IRELAND UC.
    Product Code
    JWH
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    WI, US
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    MY REPORT NUMBER IS MW5170929-DR. I WOULD LIKE TO ADD SOME ADDITIONAL INFORMATION. FOR INSTANCE, I NEED TO CLARIFY THAT THE LETTER SENT BY JNJ SAYING I SHOULD TALK TO MY DOCTOR ABOUT THIS ISSUE SOUNDS CRAZY. I'VE ASKED MY SURGEON WHAT HE FELT THE REASON BEHIND THE BUTTON BREAKING AND THE COMPONENT BEING LOOSE AND ROCKING. HE SAID ONE OF THE PEGS WAS UNSCREWED CAUSING IT TO PULL AWAY FROM THE BONE. THE CT SCAN SHOWED: CHRONIC LOOSENED SUPERIOR PATELLAR BUTTON. LOOSE CEPHALAD MEDIAL PATELLAR BUTTON. CHRONIC BUT SLOWLY PROGRESSIVE PROCESS SEEN THROUGH MULTIPLE EXAMS BEGINNING (B)(6) 2016 AFTER (B)(6) 2016 ARTHROPLASTY. NO FRACTURE. SINCE THE REVISION. I AM STILL HEALING VERY SLOWLY. MY RIGHT KNEE AND FOOT HAS BEEN CARRYING THE BILL OF THE JOB AND IS SO PAINFUL. MY RIGHT FOOT AND RIGHT KNEE DIAGNOSED AS SEVERE AND NEEDS SURGICAL INTERVENTION. SO, I AM PREPARING FOR THAT. I REALLY THINK IT SUCKS TO GO THROUGH PAIN AND SUFFERING FOR 7 YEARS FROM DAY ONE. I AM LISTING THE DEVICES THAT WERE EXPLANTED BELOW IN ADDITIONAL COMMENTS. MODEL# 151820035, LOT# 8214794 COMPONENT PATELLAR MEDIALIZE DOME 35MM CEMENT ATTUNE, IMPLANTED (B)(6) 2016, EXPLANTED (B)(6) 2025, JOHNSON AND JOHNSON. MODEL # 151640305, LOT# 623552, MMIS TIB KNEE ATTUNE 35MM AOX POSTERIOR STABILIZE INSERT; IMPLANTED (B)(6) 2016, EXPLANTED (B)(6) 2023, JOHNSON AND JOHNSON. REF REPORTS: MW5170929, MW5170929-1.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    889720 MMIS TIB KNEE ATTUNE 35MM AOX POSTERIOR STABILIZE INSERT PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL JWH DEPUY IRELAND UC. 151640305 623552

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Female Disability| H| O| R