Material Science Expert Witness Opines on Faulty Knee Implant

This case involves a patient who suffered a serious orthopedic incident following a failure of a prosthetic knee system. The Plaintiff had the prosthetic knee for several months before it failed. The particular knee replacement system was a modular design that failed at the point where the prosthetic was attached to the femur, and it appeared that the joint was machined improperly. Corporate documents and the FDA’s MAUDE database reveal that there have been multiple reports of adverse events regarding the fracture or failure of the same type of components that failed in this incident. It was alleged that the series of knee implants had been manufactured defectively, and that the company that produced the prosthesis was aware of the risk yet failed to take any action to address it.

Question(s) For Expert Witness

1) Have you ever evaluated knee prosthesis for manufacturer defects?

Expert Witness Response E-007908

I have conducted failure analysis on dozens of similar medical devices over the years, including an investigation of the failure of a metal knee joint and bone plate prostheses. I frequently handle cases of this nature and conduct metallurgical testing on similar knee devices. I managed a biomechanical testing lab for several years, where I also directed R&D. I'm very comfortable with this subject matter and the task at hand. As mentioned in the case summary listed above, there are a number of failure incidents associated with this kind of implant, all of which tend to have the same details. This shows that there is a consistent issue in the design and/or manufacture of this particular implant. It is concerning that the manufacturer may have been aware of issues with the device, yet did nothing to address the problem.