1. EPIC FAILURES IN KNEE REPLACEMENT Suzanna, Sara, Ramana, Corey

2. Need for the Product  Post-traumatic arthritis- serious damage to the knee due to a traumatic event  Rheumatoid arthritis- membrane that surrounds the joint becomes inflamed and thickened. The inflammation can damage the cartilage  Osteoarthritis- wear and tear to the knee due to age

3. Design Proposed for the Product  To Remove the arthritic cartilage and underlying bone and resurface with metal implants on the femur and tibia. Place a plastic between the implants.

4. Results of Product Dilemma  Zimmer Knee Replacements were coming loose and needed to be replaced at a faster rate than other companys’ products. To fix this, they created a glue that was more adhesive and safer for the bones as well as using materials that were more durable.

5. Prototypes  Zimmer Nexgen  Original models had various hinge systems  Harsh movements

6. Current Problems  They do not have a wide variety of uses  They can only be used for simple everyday tasks

7. Testing  They are stress tested  Many fatigue tests are done  Materials are tested to make sure they are safe for tissue and bone.

8. Quality Control Procedures  They have to meet the requirements set by ISO (International Organization for Standardization)  They are quality checks to make sure the materials are not to cheap quality

9. Product: Used, Removed, or Improved  The artificial joints should last for almost 10 years if everything went well.  If there are any problems, then they wear out quickly in 1 year.

10. Challenges  They are not very easy to implement.  They are not very cheap.  It is hard for common people to afford

11. Regulations  Regulations are maintained by the law.  There are also international regulations regarding prosthetics in general.

12. Manufacturing and Safety Issues  Companies are required to make report the results of the product and material testing to make sure that they meet the requirements  There is also a major safety concern among the people who get an artificial joint.  People are concerned about quality of the product they will get.

13. The Case Failure  The Zimmer nexgen company did not use glue on the femur bone  The prosthetic never stayed in place.  They had continuous problems in mobility.  The end of the prosthetic stayed loose.