Hey I had a similar curiosity as well. I don’t have an answer to your question but I wanted to share my curiosity as it falls along the same lines. The FDA regulates medical devices and drugs before they are sent to the market. Yet, about one third of medical devices and drugs have failed (recently) in patients or in the shelf. Where do you think the fault of these failures lie? In the manufacturer for lack of proper testing? the FDA who was supposed to inspect these devices/drugs for failure beforehand? or maybe neither, the failure was caused because of the patient’s body type or conditions?
I was curious about this because I was wondering what led to the failure of the 2012 hip-implant failure by Stryker.