Zimmer NexGen Knee Replacement

Jhalen, Mattson, Austin, Tyler, Lisa

Zimmer NexGen Knee• At the time of the invention, the need of the

product was to replace the knee joint.

• The solution was to create a whole new surgery to replace the loose knee with a new artificial device.

Materials

• The artificial knee has materials that are new to the industry of artificial body parts.

• These new parts went under a new method of inspection, making sure they were safe and reliable.

• Each prototype of the NexGen device was made of slightly different materials and smaller parts.

Current Problems and the Impact on Society

• Problems include knee replacement failure, knee pain, infection, tissue damage, bone loss, loosening of replacement knees, parts becoming detached during surgery, and device damage during surgery due to complicating parts.

• This impacted society because thousands of people have used this knee replacement system.

• The FDA listed over a hundred Class ll recalls for the components. People today are still suing Zimmer Knee Replacement System.

Zimmer NexGen Knee

• New surgery procedures included having an orthopedic surgeon at all times and installing the parts the very same every time.

• Since the release of the knee replacement system, it is still usedtoday.

• Multiple parts have been replaced, but the current problems have been resolved.

Technological Challenges

• The product has been designed to be self-sustainable without testing it in an actual human.

• The problem with not being able to test the product in an actual person is that you don’t know 100% if the materials and over-all product will withstand everyday use.

Regulations, Guidelines, and Practices that Insure Safety

• Specific tests and experiments are mandatory when developing a product to ensure durability.

• They should experiment with other materials and

designs to make sure that it is safe and healthy.

• The FDA requires that the implant manufacturer is legally responsible for marketing the product properly and adequately warning consumers and health care professionals about the risks of that given product.

Manufacturing and Safety Issues

• Premature loosening, limited mobility, severe pain, infection, inflammation and swelling, and bone, joint, muscle, or neurological damage are problems that are hard to control when implementing this product.

• For the manufacturer, if one of the parts fails, then they are liable for the broken parts and it becomes an issue of the company.

Did the Product Fail

• Yes, some of the parts did not last as long as expected.

• Some improvements could have been made to make it out of stronger materials.

• Those material changes could have been cost effective if they added the extra materials cost to the final product cost.

Improvements and Liabilty

• With better materials to improve the bad part, the problems would have been solved and the parts would be durable enough for re-use.

• It was a liability of the engineer for creating faulty parts, but in the end the company is the one who is selling the product & getting sued and not the engineer.

Manufacturing Centers

• Warsaw, IndianaManufacturing Center

• Winterthur, Switzerland Facility

• Shannon, Ireland Manufacturing Center