BME402 Design and Regulatory Assessment of a Cemented Knee Implant

Assignment 3000 +/-5% words

?The goal of this assessment is to develop a new implementation of KNEE as a company.

1.Demonstrate systematic knowledge and understanding of design processes and methodologies and the ability to apply and adapt them in unfamiliar situations.

2. Demonstrate systematic knowledge and understanding of the relevant regulatory requirements governing engineering activities in the context of Biomedical Engineering.

3. Demonstrate the ability to understand different roles within an engineering team and to exercise initiative and personal responsibility, which may be as a team member or leader.

Introduction

The knee is one of the largest and most complex joints in the body. The knee moves like a hinge, allowing you to sit, squat, walk or jump.The knee is a type of suynovial joint where the bones of the lower and upper legs meet. The knee joins the thigh bone (femur) to the shin bone (tibia). The smaller bone that runs alongside the tibia (fibula) and the kneecap (patella) are the other bones that make the knee joint figure 1.

Tendons connect the knee bones to the leg muscles that move the knee joint. Ligaments join the knee bones and provide stability to the knee:

• The anterior cruciate ligament prevents the femur from sliding backward on the tibia (or the tibia sliding forward on the femur).

• The posterior cruciate ligament prevents the femur from sliding forward on the tibia (or the tibia from sliding backward on the femur).


• The medial and lateral collateral ligaments prevent the femur from sliding side to side.

Two C-shaped pieces of cartilage called the medial and lateral menisci act as shock absorbers between the femur and tibia. Numerous bursae, or fluid-filled sacs, help the knee move smoothly.

In a healthy Knee joint, the surfaces of these bones where the hingy like joint rub together are very smooth and covered with a tough protective tissue called cartilage. Arthritis causes damage to the bone surfaces and cartilage. These damage surfaces eventually become painful as they wear. There are many ways to treat the pain caused by arthtitis. One way is total Knee replacement surgery. in total knee replacement surgery, the damaged joint are removed and replaced with artificial parts made of metal and a durable plastic material. There are tow main typ of fixation philosophies cemented and porous. Both can be effective in the replacement of knee joints.

In this instance, cemented knee replacement will be considered. The cobalt chromium knee implant, shown in figure 2a, is designed to be inserted into the prepared tibia canal and femur with the use of bone cement. Initially, the femoral site and the tibia canal are prepared so that the implant fits tightly within it. The cement will apply to the canel and interface between implant and bone. Eventually, this fixure method will provide long-term fixation to hold the implant in the proper position. The plastic component is then inserted between femoral and tibia components after the stem has been inserted in the tibia canal and ready to be connected to the femoral components figure 2b. The assembled reconstructed Knee is shown in figure 2c.

Tasks

The assignment concicts of two sections.

You are required to answer both sections and submit a report no longer than 3000 words. You can use tables, figures and other pictorial means to help you answer the questions.

SECTION 1: MEDICAL DEVICE DIRECTIVE (40%)

In section one, assume that you want to introduce a new cemented Knee implant and have the product CE marked. Referring to medical device directive (MDD) documents:

(1) Classify the total Knee procthesis giving reasorces for your choice of classification,

(2) List down the activities and requirements that you need to carry out/meet in order to be in conformity with the MDD. Please quote which Annexes and Essential Requirements you are using to answer the question.

SECTION 2: RISK ANALYSIS AND FMEA REPORT (60%)

In section two, as part of the documentation required to get approval from the MHRA (Medicines and

Healthcare products Regulatory Agency) to carry out the clinical trials, carry out risk analysis of the total Knee prosthesis based on the questions set in BS EN ISO 14971:2019 Appendix 2. Also carry out a failure mode and effects analysis (FMEA) to identify as many control measures as possible to reduce the probability of occurrence of all potencial hazards identified in the risk analysis.

Format, structure and Grading system Strictly observe the structure below.

The report should include:

assignment title. Cemented Knee Replacement

??An abstract, summarise the problem/task set, the method used. (Max 300 words)

?? Table of Contents

?? Introduction. outline the steps taken to design and manufacture an artificial total Knee.

?? Medical Device Directive

?? Anatomy of Knee joint

?? Classify the Total Knee replacement

??Activities to be in conformity with the MDD

??Risk analysis and FMEA report (the FMEA report should be more detailed and expanded with more information.

??Risk analysis of the total Knee prosthesis

?? Failure mode and effects analysis

??Conclusion This should sum up the main points of your report. Do not introduce new material. The points made here should relate and flow logically from the both sections in your device development procedure and how they are linked.

The conclusions :

you come to should substantiate the points made in the main text. You can express opinions, provided that you have the evidence to support them. Any problems, weakness or flaws in your experiment should be acknowledged in this section.

??Bibliography (using Harvard system)

It is expected that the Reference List will contain between fifteen to twenty sources.

As a MINIMUM .

?? Appendix