BEUDAMED
    FDA Adverse Event Other Summary report: N

    FEMORAL IMPLANT IMPLANTED

    MDR report key: 20480353 · Received October 17, 2024

    Report

    Report Number
    MW5161195
    Event Type
    Other
    Date Received
    October 17, 2024
    Report Date
    October 10, 2024
    Manufacturer
    CONFORMIS, INC.
    Product Code
    JWH
    Report Source
    Voluntary report
    Reporter Location
    OH, US
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    INCLUDED IS THE DOCS FROM A KNEE REPLACEMENT. IT HAS ALL THE DETAILS OF THE UNIT USED ON (B)(6) 2016. ALSO INCLUDED IS THE PROOF OF A REVISION THAT HAD TO BE DONE DUE TO THE 2016 UNIT FAILING. (INCLUDED IS AN XRAY OF FIRST JOINT REPLACEMENT IN (B)(6) 2024.) WHILE I HAVE SEARCHED FOR A REPORT ON THE FIRST UNIT WITH THE FDA, I HAVE FOUND NOTHING REPORTED. I HAVE INCLUDED A PICTURE OF THE FAILED KNEE REPLACEMENT. ALL DOCUMENTS AND SURGERIES ARE THROUGH (B)(6). IF ANY ADDITIONAL PROOF IS REQUIRED, I CAN PROVIDE WHEN NEEDED. THE REVISION WAS DONE ON (B)(6) 2024 AFTER SUFFERING PAIN FOR 7 YEARS. AFTER THE SECOND SURGERY, I DID CONTACT LAWYER ABOUT A WAY TO HANDLE THE CASE AND THIS IS THE FIRST ACTION IS TO START THE PROCESS. THANK YOU. AT THIS TIME, I HAVE SPENT OVER (B)(6) DUE TO A SURGERY THAT WAS CAUSED BY A FAILED KNEE REPLACEMENT UNIT. FAILED TOTAL KNEE ARTHROPLASTY (HCC) LEFT KNEE PAIN. REF REPORTS: MW5161193, MW5161194, MW5161196, MW5161197, MW5161198.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1874217 FEMORAL IMPLANT IMPLANTED PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL JWH CONFORMIS, INC. TCR1211111-FI

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female