Cemented Knee Prosthesis Assignment Sample

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Introduction: Cemented Knee Prosthesis

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The complex of the knee's synovial joint has recognised the prosthesis's compressive analysis. In that case, the knee is the prominent joint where the lower and upper bones of the legs meet each other. The lower bone and the upper bone of the knee joint can be run alongside the tibia and the patella. The lower joint of the knee can be helpful for the significance of effective knee joint replacement therapy. The replacement majority aspects can be evaluated by the risk management and the implementation of the mitigation strategy. The regulatory standard can be reliable to ensure the safety majors of the suffering patients.

Medical Device Directive

Anatomy of the Knee Joint

In the human body, the knee joint is the largest joint which includes several structures. It is mainly composed of tendons, ligaments, bones, muscles, and cartilage. This specific structure can be specified by the following figure. Several parts are included in the effective structure of the knee joint. It is mainly composed of several muscles which can be effective for the movement of the leg. The following four bones are included in the knee joint specifically.

Femur: It is mainly the thigh bone and it is also the largest and strongest bone of the human body part. Femur is a critical part of the movement majority of aspects of the legs of humans (Banger et al. 2020). It mainly supports the ligament, tendons, and muscles in the movement of the circulatory system.
Tibia: it is the stronger bone of the legs and it mainly helps to manage the body weight as it is known as the “weight-bearing bone” of the human body (Rivière and Vendittoli, 2020). It is the doppelganger of the fibula. It helps to join the knee with the femur.
Patella: it is mainly the type of sesamoid bone of the human body part which is mainly located in the anterior part of the knee joint. It provides an extension to the main joint of the knee of the human body (Messner and Gao, 2021). The critical majority aspects of the knee muscles must keep safely by the patella bone. The effective structure of the knee bone can keep the infrastructure of the knee joint.
Fibula: It is the long bone of the lateral side of the tibia bone. It is mainly located at the thinner bine of the tibia (Ghomrawi et al. 2020). The knee joint is run to the ankle joint with the help of the Fibula and tibia bone. It helps to circulate the structure of the knee joint.

Figure 1: Anatomy of the knee joint

(Source: Ghomrawi et al. 2020)

Ligaments: It mainly covers the “Anterior cruciate ligament”, “Lateral collateral ligament”, “posterior cruciate ligament” and “Medial collateral ligament”. It helps to hold the knee joint perfectly.
Tendons: it is a crucial component that is linked with the muscle and ligaments perfectly.
Bursae: It is a sac-like structure that helps to decrease the friction of the knee joint.

Classify the Total Knee replacement

The knee joint can be replaced by the basic structure of the knee replacement therapy of the human being. The technological aspects can be replaced by the key consideration aspects of the replacement therapy. The majority of aspects of effective function and durability can be recognised by the function and better design of natural motion of the perfect manufacturing aspects of the clinical study (Mikkelsen et al. 2021). The study design can be determined by the durability aspects of the critical consideration aspects of knee replacement therapy. It can remove the joint pain in the knee. The determination quality of the effective major can be evaluated by the effective majority aspects of the patient care and mental components perfectly. The metal part of the tibia components can be inserted by the ethical aspects of the critical part of the knee joint.

Figure 2: Knee replacement

(Source: Mikkelsen et al. 2021)

The acrylic substance can be recognised by the quality control aspects of knee replacement therapy. The suffering patient must be very careful about their health-related purpose and also habituated to the suspected majority aspects of the clinical treatment. It can help to observe the patient's condition in the hospital sector. It can help to support the surrounding tissues and the muscle of the knee.

Activities to be in accordance with the MDD

To assure that the total new knee prosthesis that is in accordance with the “Medical Device Directive” (MDD), and the following exertion that will be carried out.

Risk Analysis: Direct the analysis of a “comprehensive risk” of the medical device in identifying the potential hazards and mitigating the risks linked with the utilization of the device.

Clinical Analysis: Direct the analysis of a clinical of the medical device in ensuring effective and safe in terms of utilization of the medical devices. The analysis of clinical must be relevant to the clinical data, like the trials of clinical, surveillance data of post-market and published literature.

Technical Documentation: Prepare the documentation of the technical file comprehensively that indulges information related to the design of the device, performance, manufacturing, and features of safety.

System of Quality Management: Execute the system of “quality management” that is (QMS) that assembles with the need of the “Medical Device Directive” that is (MDD) (Kaptein et al., 2020). The system of quality management must cover all features of the design of the device, distribution, and manufacturing.

Assessment of Conformity: Direct the process of the assessment of conformity, which indulges analyzing the compliance of the device with the requirements of the essence of the “Medical Device Directive”. This process might indulge the presence of a “Notified Body”, that is the organization of a “third party” that has been authorized by the “European Commission” in assessing the conformity of the medical devices with the “Medical Device Directive”.

Surveillance of the Post-market: Implement the surveillance system of a “post-market” in monitoring the performance and safety of the medical device after the device that has been placed in the market (Affatato et al., 2021). The system must indulge the procedures for analyzing and collecting the events that are adverse, complaints, and other data that are relevant.

Requirements for conformity with the MDD

The effective activities of knee joint anatomy can be emphasized by conformity to the requirement of the MDD. Best performing aspects of the risk analysis of the knee joint structure can be evaluated by specific problems and the basic analysis process. It mainly involves several questions as well as supportive answers to the basic outlines. The medical device directive (MDD) mainly requires the essential requirement of the medical products in the basic performance requirements (Skrejborg et al. 2019). The quality control products of the knee joint anatomy can be evaluated by the affirmative structure of the essential requirements. The questions and answers are followed by the key consideration of the MDD.

Several indications are used to identify the total dependent aspects of the knee prosthesis. It mainly includes different clinical conditions to overcome the related issues of the knee joint. Clinical conditions can be evaluated by considering aspects of the effective aspects of the basic techniques.
Potential hazards are mainly associated with the implementation of the device of implant dislocation (Leung et al. 2020). In that case, the majority of aspects can be considered the infection and basic failure of the knee joint anatomy.
Several harmful structures can be evaluated by the impact of the infarction of the human body part. The segmental aspects can be implemented by the frequency distribution and harmful risk management of the anatomical sectors.
Most likelihoods must occur by the risk management of the identification hazard. The eliminated risk factors can be effective for the critical evaluation aspects critically.
The basic identity major must be effective for the key consideration aspects of the modification approaches of the instruction. This post-marketing surveillance must be labelling by the mitigation strategy of the identification measures of the knee joint and the risk management of the specific structure.

Risk Evaluation and Report of FMEA

Risk Evaluation of the whole prosthesis of Knee

Criteria	Description	Potential Hazards
C.1. What basis does the serve of prosthesis knee, and how it can be applied?	The deliberated utilization of the prosthesis provides the replacement for the “knee joint in patients with the damage in the knee joint very severely or disease, who are encountering significant stiffness, pain, or disability that might not be managed adequately with the treatments of non-surgical. The device eventually consists of the component of the femoral, the component of the tibia, and “a plastic spacer” that manifests as the cushion in between the components (Jacquet et al., 2021). The components of prosthetics are mainly designed in mimicking the natural movement and shape of the “knee joint” enabled for the improved motion range and reduced stiffness and pain.	Not Applicable
C.2. Is the design of the medical device to be “implemented”?	The prosthesis of the knee is manifested to be “implanted” in the human body throughout the procedure of surgical. The medical device has been designed in replacing the diseased or damaged joint of the knee and is eventually fixed in a place utilizing “bone cement” or other methods of fixation (Batailler et al., 2020). The process of implantation needs a surgeon who is skillful, “careful in preparation”, and planning in ensuring the optimal alignment and placement of the component of the prosthetic.	Not Applicable
C.3. Is it deliberated for the equipment of medical in coming into “contact with” the people or patient	Prostheses of the knee are deliberated to be “in contact with” the body tissues of the patient, fluids, and bones. The components of prosthetics are being made of the materials of biocompatible such as plastic, metal, or ceramic, that are designed in minimizing any probable adverse reactions or responses of immune by the “patient” (Jacquet et al., 2021). The device has been implanted inside the “knee joint” and is deliberated to be “in contact with” the bones, tissues, and fluids of the surrounding on the basis of permanent.	Not Applicable
C.4. What parts or substances are being employed in the “medical device”, in coexistence with the prosthesis, or coming in contact with it?	The prostheses of the knee eventually consist of the component of the femoral, which has been “made up of metal” the component of the tibial “made of metal”, plastic, or their combination (Batailler et al., 2020). Antibiotics that perhaps be utilized in reducing the infection risk throughout the follow-up and implantation of the device care.	The components and materials utilized in the prostheses of the knee can probably cause harm such as plastic or metal wear debris, the toxicity of bone cement, allergic reactions, and complications of the surgery, and professionals of healthcare should take proper measures in minimizing the threats.
C.5. Is the manufacturing of the medical device to be “implemented”?	The manufacturing of the medical device is manufactured in the replacement or the damaged joint of the knee and is eventually fixed in a place utilizing “bone cement” or other methods of fixation (Hampton et al., 2020).	Not Applicable
C.6. Is the medical devices encounter the person suffering from the problem?	The medical device is not deliberated to be “in contact with” the person necessary precautions must be taken in minimizing the infection risk of contamination or infection throughout the follow-up and implantation care (Hampton et al., 2020).	Not Applicable
C.7. What segments are being employed in the “medical device”?	Spacers of plastic made up of polythene of molecular weight, which is ultra-high, bone cement, instruments of surgical, lubricant of the prosthetic joint.	The toxicity of bone cement, allergic reactions, and complications of the surgery,
C.8. How is the serving of prosthesis knee applied?	The device eventually consists of the component of the femoral, the component of the tibia, and “a plastic spacer” that manifests as the cushion in between the components.	Not Applicable
C.9. What is the condition after the implantation of the prosthesis of the knee?	Once the implantation of the joint of knee the prosthesis has been done, it becomes a “permanent part” of the anatomy of the patient (Jameson et al., 2019).	Not Applicable
C.10. What is the after-effect of the prosthesis of the knee?	The prosthesis remains “in place” in the person’s body for the “rest of their life”, and requires revised surgery.	Not Applicable
C.11. What is the mitigation of the prosthesis of the knee?	Mitigation could be done or the knee prosthesis could remain in place once the proper treatment should be kept under treatment and proper maintenance should be made.	Not applicable

Table 1: Criteria for the Risk Evaluation of the whole prosthesis of Knee

(Source: Self-Made)

Failure Mode and Effect Analysis

[1] Fracture

Inappropriate Implantation method- The nascent stage of pregnancy during which the nascent embryo attaches to the wall of the uterus. Through this attachment, the fetus received nutrients and oxygen for the better growth of the embryo(Yapp et al., 2021). There could be several reasons behind the inappropriate implantation method implantation is incomplete, embryo transfer is improper, ovarian response which is poor, egg quality might be poor, the internal environment might be poor, or under certain special conditions.

Fatigue failure- The formation and the propagation of the cracks for the cyclic load and the repetitive cycle could be caused by the cyclic loads which certainly would give results below the overall yield of the material.

Inaccurate assessment of bone quality- In several cases, the methods like "DEXA scan" has been considered to be the "gold standard" or the test which are more accurate. The measurement tells the provider to be healthcare, (Sloan et al., 2020) for the decrease of the mass of the bone. This particular condition is where the bones are more prone to breakage in an easier way.

Product Defects- Products like surgical instruments or equipment may possess any kind of defect which might not be visible or might have a hindrance to the overall usability which has been designed and manufactured in any other way.

[2] Size of the kneecap post-surgery

Poor measurement and incision of the surgeon- Problems that are in general faced by surgeons including the measurements which are generally poor and the surgeon may have an incision or any other defect regarding their instruments or measurements.

Incompatible characteristics that the material may have- Incompatibilities like defects in certain equipment or any other defects related to surgical equipment might be incompatible and have certain characteristics which might affect the analysis and would cause failure (Laoruengthana et al., 2019).

[3] The prosthesis of the misalignment

Procedure and technique and its incorrect fixation- There might be certain techniques that are incorrect and could not be fixed properly.

Rehabilitation or follow-up which is inadequate- After the procedure or analysis, rehabilitation or adequate follow-up must be needed which might be not done for the case of the procedure (Ali et al.,2019).

[4] Prosthesis and its loosening

Designs that are incorrect fixation and have an ineffective procedure- The designs of the equipment might not be fixed properly and might have certain methods or ineffective methods that could not be improved further the analysis could be difficult to be made.

[5] Infections

Infection control in an inefficient way- Infection control could be the most important measure for the effective control of the spread of disease, which could be done inefficiently.

Poor bone quality and allergic reactions effects

[1] Fracture

Inappropriate Implantation method- This could lead to several maternal problems which could cause the mother to affect her reproductive procedures and may cause several pain and inflammation of the patient and her organs (Matziolis et al., 2020).

Fatigue failure- The performance of the implantation is anticipated, and the experiences of the patient are painful and inflammatory.

Inaccurate assessment of bone quality- Poor fixation of the implantation and its failure consecutively.

Product Defects- This could cause a better revision of the surgery and its interventions could be done properly.

[2] Size of the kneecap post-surgery

Poor measurement and incision of the surgeon- There may be difficulty for the patient in the process of bending the knee, further developing the posture in a bad position, and also hampering the activities which are daily performed (Burn et al., 2019).

Incompatible characteristics that the material may have defective local or the systemized defect of the tissue in all overall.

[3] The prosthesis of the misalignment

Procedure and technique and its incorrect fixation- This may cause swelling and pain in the affected area for further reduction of the mobility of the patient.

Rehabilitation or follow-up which is inadequate- This might cause the failure of the implantation or the reduction of the mobility of the patient or the affected person.

[4] Prosthesis and its loosening

Designs that are incorrect fixation and have an ineffective procedure - This causes the reduction of the pain and the swollen condition.

[5] Infections

Infection control in an inefficient way- The infection should be controlled in a better way so that it is not efficient.

Poor bone quality and allergic reactions- The allergic reactions might cause the worst quality of the bone, causing, more effects on the patient (Zhao et al., 2020).

Mitigation

Mitigation procedures have been discussed further for the overall improvement and recovery of the condition of the patient. The mitigation should be done in a proper method so that, the hazard may not happen further or secondarily.

Conclusion

The conclusion could be linked further with the overall topic of the study. The introduction could be centered and cemented for the prosthesis of the knee and it's an important task for the overall milestone in the field of surgery which is done by the orthopedic. The development f the device which has been used in medical research, the activities have been seen to be involved extensively and the overall requirements could include the analysis of the risk and the modes of failure and the effective analysis for this analysis.

The knee prosthesis has been classified based on the "MRD Annex" classification for the device, which certainly needs the strategies of management. The development and the risk analysis of the "FMEA" could be identified for the modes of failure and its effective patients and its potential, allowing the approximate measures of the risk control management and various other things. The newly introduced cemented knee generally meets the overall requirements of the "MDR", which certainly includes the requirements for the overall safety and its performance which could be standard and based on the relevant harmonized analysis.

References

Affatato, S., Erani, P., Fersini, M., Contaldi, V., Terrizzi, A.R. and Licciulli, A., 2021. Preliminary in vitro wear assessment of ceramic cemented femoral components coupled with polyethylene menisci. Materials, 14(9), p.2112.
Ali, A.M., Loeffler, M.D., Aylin, P. and Bottle, A., 2019. Predictors of 30-day readmission after total knee arthroplasty: analysis of 566,323 procedures in the United Kingdom. The Journal of Arthroplasty, 34(2), pp.242-248.
Banger, M.S., Johnston, W.D., Razii, N., Doonan, J., Rowe, P.J., Jones, B.G., MacLean, A.D. and Blyth, M.J., 2020. Robotic arm-assisted bi-unicompartmental knee arthroplasty maintains natural knee joint anatomy compared with total knee arthroplasty: a prospective randomized controlled trial. The Bone & Joint Journal, 102(11), pp.1511-1518.
Batailler, C., Malemo, Y., Demey, G., Kenney, R., Lustig, S. and Servien, E., 2020. Cemented vs uncemented femoral components: a randomized, controlled trial at 10 years minimum follow-up. The Journal of arthroplasty, 35(8), pp.2090-2096.
Burn, E., Weaver, J., Morales, D., Prats-Uribe, A., Delmestri, A., Strauss, V.Y., He, Y., Robinson, D.E., Pinedo-Villanueva, R., Kolovos, S. and Duarte-Salles, T., 2019. Opioid use, postoperative complications, and implant survival after unicompartmental versus total knee replacement: a population-based network study. The Lancet Rheumatology, 1(4), pp.e229-e236.
Ghomrawi, H.M.K., Mushlin, A.I., Kang, R., Banerjee, S., Singh, J.A., Sharma, L., Flink, C., Nevitt, M., Neogi, T. and Riddle, D.L., 2020. Examining timeliness of total knee replacement among patients with knee osteoarthritis in the US: results from the OAI and MOST longitudinal cohorts. The Journal of Bone and joint surgery. American volume, 102(6), p.468.
Hampton, M., Mansoor, J., Getty, J. and Sutton, P.M., 2020. Uncemented tantalum metal components versus cemented tibial components in total knee arthroplasty: 11-to 15-year outcomes of a single-blinded randomized controlled trial. The bone & Joint Journal, 102(8), pp.1025-1032.
Jacquet, C., Ros, F., Guy, S., Parratte, S., Ollivier, M. and Argenson, J.N., 2021. Trabecular metal cones combined with short cemented stem allow favorable outcomes in aseptic revision total knee arthroplasty. The Journal of Arthroplasty, 36(2), pp.657-663.
Jameson, S.S., Asaad, A., Diament, M., Kasim, A., Bigirumurame, T., Baker, P., Mason, J., Partington, P. and Reed, M., 2019. Antibiotic-loaded bone cement is associated with a lower risk of revision following primary cemented total knee arthroplasty: an analysis of 731 214 cases using national joint registry data. The bone & joint journal, 101(11), pp.1331-1347.
Kaptein, B.L., den Hollander, P., Thomassen, B., Fiocco, M. and Nelissen, R.G., 2020. A randomized controlled trial comparing tibial migration of the ATTUNE cemented cruciate-retaining knee prosthesis with the PFC-sigma design. The Bone & Joint Journal, 102(9), pp.1158-1166.
Laoruengthana, A., Rattanaprichavej, P., Chaibhuddanugul, N., Varakornpipat, P., Galassi, M. and Pongpirul, K., 2019. Blood loss reduction: effect of different knee prosthesis designs and use of tranexamic acid—a randomized controlled trial. European Journal of Orthopaedic Surgery & Traumatology, 29, pp.1519-1524.
Leung, K., Zhang, B., Tan, J., Shen, Y., Geras, K.J., Babb, J.S., Cho, K., Chang, G. and Deniz, C.M., 2020. Prediction of total knee replacement and diagnosis of osteoarthritis by using deep learning on knee radiographs: data from the osteoarthritis initiative. Radiology, 296(3), pp.584-593.
Matziolis, G., Brodt, S., Böhle, S., Kirschberg, J., Jacob, B. and Röhner, E., 2020. Intraarticular vancomycin powder is effective in preventing infections following total hip and knee arthroplasty. Scientific Reports, 10(1), pp.1-6.
Messner, K. and Gao, J., 2021. The menisci of the knee joint. Anatomical and functional characteristics, and a rationale for clinical treatment. The Journal of Anatomy, 193(2), pp.161-178.
Mikkelsen, M., Gao, A., Ingelsrud, L.H., Beard, D., Troelsen, A. and Price, A., 2021. Categorization of changes in the Oxford Knee Score after total knee replacement: an interpretive tool developed from a data set of 46,094 replacements. Journal of Clinical Epidemiology, 132, pp.18-25.
Rivière, C. and Vendittoli, P.A., 2020. Personalized hip and knee joint replacement.
Skrejborg, P., Petersen, K.K., Kold, S., Kappel, A., Pedersen, C., Østgaard, S.E., Simonsen, O. and Arendt-Nielsen, L., 2019. Presurgical comorbidities as risk factors for chronic postsurgical pain following total knee replacement. The Clinical Journal of Pain, 35(7), pp.577-582.
Sloan, M., Sheth, N.P. and Nelson, C.L., 2020. Obesity and hypoalbuminemia are independent risk factors for readmission and reoperation following primary total knee arthroplasty. The Bone & joint journal, 102(6 Supple A), pp.31-35.
Yapp, L.Z., Walmsley, P.J., Moran, M., Clarke, J.V., Simpson, A.H.R. and Scott, C.E., 2021. The effect of hospital case volume on re-revision following revision total knee arthroplasty: A national study using the Scottish arthroplasty project dataset. The Bone & Joint Journal, 103(4), pp.602-609.
Zhao, H.Y., Yeersheng, R., Kang, X.W., Xia, Y.Y., Kang, P.D. and Wang, W.J., 2020. The effect of tourniquet uses on total blood loss, early function, and pain after primary total knee arthroplasty: a prospective, randomized controlled trial. Bone & joint research, 9(6), pp.322-332.