BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TOTAL KNEE REPLACEMENT CEMENT KLASSIC TOTAL KNEE SYSTEM

    MDR report key: 10425333 · Received August 18, 2020

    Report

    Report Number
    MW5096129
    Event Type
    Injury
    Date Received
    August 18, 2020
    Date of Event
    December 9, 2019
    Report Date
    August 15, 2020
    Manufacturer
    TOTAL JOINT ORTHOPEDICS, INC.
    Product Code
    JWH
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TX, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    I HAD KNEE REPLACEMENT (B)(6) 2017. BEGAN EXPERIENCING PAIN LIKE IT WOULD NEVER HEAL. IN 2019 ORTHOPEDIC SURGEON SAID REVISION SURGERY WAS NEEDED BECAUSE THE CEMENT WAS NOT ADHERING TO THE PROSTHETIC. HAD REVISION DONE (B)(6) 2019. STILL IN PAIN. PLEASE HELP. THIS WAS KLASSIC TOTAL KNEE REPLACEMENT FROM TOTAL JOINT ORTHOPEDICS. CEMENT LOOSENED ON TKR; THIS PROSTHETIC NEEDS TO BE INVESTIGATED. THE FDA SHOULD NOT HAVE APPROVED 510(K) NUMBER K183596. FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    882878 TOTAL KNEE REPLACEMENT CEMENT KLASSIC TOTAL KNEE SYSTEM PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL JWH TOTAL JOINT ORTHOPEDICS, INC. UNK UNK
    882879 TOTAL KNEE REPLACEMENT CEMENT KLASSIC TOTAL KNEE SYSTEM PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL JWH TOTAL JOINT ORTHOPEDICS, INC. UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Hospitalization| O