7 of the Top Medtech Horror Stories7 of the Top Medtech Horror Stories

1. The Failure of Metal-on-Metal Hip ImplantsIt wasn’t long ago that metal-on-metal hip implants were hyped as a game changing technology. All-metal implants were thought to be stronger than other types of implants with the exception of those made of ceramic, which are hard yet brittle.“I learned a lot about tribology (surface contact lubrication) over the years. The number one thing was that you do not ever use similar materials or hardness in sliding contact. No matter how good the surfaces or lubrication, at some point they will gall and then failure starts,” says David Hajicek, a longtime Twin Cities medical device electrical engineer. (His quote was part of a discussion on LinkedIn’s Medical Devices Group.)A host of large medical device companies, however, held a different view --believing that metal-on-metal would provide hip implants that would last longer and allow younger patients to stay active.It turns out they were wrong. First introduced in the late 1990s, metal-on-metal hip implants have had serious issues. Undergoing wear and tear, the implants in some cases have released chromium and cobalt ions. These ions can seep into local tissue near the site of an implant, potentially destroying bone and muscle. If these ions manage to enter a patient’s circulatory system, they can injure the kidneys, liver, spleen and lymph nodes before elimination from the body through urine.The devices have tragically become a bonanza for lawsuit lawyers. Jury selection started last week in the first of about 6,000 claims against Johnson & Johnson’s DePuy subsidiary over its Pinnacle artificial hip. Plaintiff Kathy Herlihy-Paoli alleges in her complaint that she suffered metallosis—a result of cobalt poisoning—due to large amounts of metal debris left in her body by the cobalt and chromium artificial hips. She claims to have had the hips removed due to infections.The Pinnacle artificial hip is not covered under the company’s earlier $2.5 billion settlement of about 8,000 claims over DePuy’s ASR artificial hips. DePuy recalled the ASR metal-on-metal hips in 2010.