In agreement with ashley, it is not the responsibility of the company to retest their device, especially since they are not making any claims about extreme sports. Also, according to the FDA Mission statement, “The Food and Drug Administration is responsible for protecting the public health by ensuring the safety, efficacy, and security of human and veterinary drugs, biological products, and medical devices”. Since they are properly regulating the the safety, efficacy, and security or hip implants for intended use, secondary approval is not necessary. However, I believe to properly address this issue, the FDA would have to create a new classification for high activity implants, allowing companies to choose the rating of implant they want to produce. this would improve safety for all parties seeking a higher mobility lifestyle for the implant recipient.

as far as advertising is concerned, the FTC would likely be responsible for misleading hospital advertising since they are not actually producing the device. as stated on the FDA website, “The FTC protects consumers by stopping unfair, deceptive or fraudulent practices in the marketplace.”

https://www.fda.gov/AboutFDA/WhatWeDo/
https://www.fda.gov/AboutFDA/Transparency/Basics/ucm194879.htm