DePuy or Not DePuy: When Medical Devices Go Very, Very Wrong

Things took a darker turn with the story of DePuy’s ASR hip replacements, a medical device that promised mobility but ended up causing chaos inside the body.

The ASR model used an all-metal design, which turned out to be a massive problem. Over time, metal debris would shed into the bloodstream, leading to serious health issues like metallosis, pseudo tumours, and even cognitive decline. The worst part? It skipped the usual rigorous safety checks thanks to a fast-track approval route known as the 510(k) pathway.

By 2008, more than 100,000 of these devices had been implanted around the world, raking in over $1 billion in sales. But the fallout was huge. Thousands of patients suffered, and DePuy eventually had to pay out $2.5 billion in settlements.

It’s a case that raises big questions about medical ethics, corporate responsibility, and how something so dangerous made it into so many bodies. 

About Simon and Danielle:

Simon and Danielle are both business owners, based in the East Midlands, who met through mutual business contacts and who share a love of all things business. 

Simon runs Skylight Media – Award-winning experts in Website Design, E-commerce & Marketing running since 2003.

Danielle runs Goldspun Support – a multi-faceted support service for fractional directors and small business owners across the globe, running since 2009.

Since they first met Simon and Danielle have spent a ridiculous amount of time talking about the subjects that interest them – usually over a drink in the pub – and they decided that now was the time to bring these conversations to a wider audience and invite them to join the chat. 

Both Simon and Danielle are successful business owners in their own rights with big plans for the future but will never lose their love of talking all things business… and the pub.

Transcript

Danielle: Good afternoon.
Simon: I was going to say that.
Danielle: No, I said it first. You’re never going to beat me. I’m going to say it every time.
Simon: Fair enough. Okay, right. Yes. How are your hips, Danny?
Danielle: If I’m honest, they’re not that great.
Simon: Oh god, are you struggling to walk?
Danielle: No, not quite. I just couldn’t sit in teddy bear for a long time.
Simon: Sit in what now?
Danielle: Teddy bear. When your legs are out to the sides and you stretch forward down the middle.
Simon: Oh. Okay. It’s called teddy bear?
Danielle: Yeah.
Simon: That sounds a bit wrong.
Danielle: Well, maybe, but it’s a real stretch. Anyway, my hips aren’t great. Thanks for asking. I do get a bit of pain.
Simon: You need to watch out for that.
Danielle: I probably should. I’m getting old.
Simon: My mum’s 85 this year. She’s got a really bad hip. She’s on the waiting list for a replacement, but she’s in absolute agony. She won’t take painkillers because she says they hide the truth and make her feel groggy.
Danielle: But she’s retired, right? She could take a nap.
Simon: She doesn’t like a fuss. It’s a generational thing.
Danielle: Bless her. Hips take a lot of strain.
Simon: They do. And increasingly, more people are getting them replaced.
Danielle: Yeah. My mum had hers done in her 50s. The doctors said it was too early, that she’d need it redone later, but she has degenerative arthritis.
Simon: That’s hereditary, isn’t it?
Danielle: Yeah. So that’ll be nice for me.

Simon: That’s one of the reasons for hip replacements, when pain and stiffness affect your life. Injuries, fractures, diseases like osteoporosis or arthritis, even bone dysplasia. Physiotherapy and drugs don’t always help.
Danielle: There’s not enough cod liver oil in the world.
Simon: There are different types of joints: metal plus plastic, and ceramic. Want to guess when the first hip replacement was done?
Danielle: The 1950s?
Simon: Way earlier. 1891. A guy named Themistocles Gluck replaced a femoral head with ivory.
Danielle: Without anaesthetic?
Simon: Probably had a wooden spoon to bite on. But yeah, developments moved on during the wars, especially in the 40s, and by the 50s and 60s, they were fairly commonplace.

Simon: So today, I want to talk about the DePuy orthopaedics hip replacements.
Danielle: That’s a Johnson & Johnson company, isn’t it?
Simon: Yep. They developed the Pinnacle and the ASR systems. The ASR had a total hip (the XL) and a resurfacing version. The total one replaced the whole head and socket. Resurfacing just coated the ball and cup.
Danielle: Right.
Simon: The Pinnacle got approved in 2003, and the ASR in 2005. But the ASR is where the issues really came in. It was created to compete with the Birmingham Hip Resurfacing system which was already popular. DePuy didn’t want to lose market share, so they developed fast.
Danielle: Always a red flag.
Simon: Yep. It got approved under what’s called a 510(k) process, a “similar equivalent” route.
Danielle: Meaning it didn’t go through full clinical trials?
Simon: Exactly. It was considered similar enough to an older device, so it skipped direct testing in humans. It was all-metal, cobalt chromium alloy.
Danielle: That sounds squeaky.
Simon: The idea was it would be longer-lasting, more flexible, ideal for younger, more active people. But what happened was, within a few years, these are meant to last 15, the components started to break down.
Danielle: Metal on metal. Grinding. Friction. What could go wrong?
Simon: It released microscopic metal particles into the surrounding tissue and bloodstream, causing adverse reactions, metallosis, tissue death, pseudo-tumours.
Danielle: So basically poisoning people.
Simon: Yes. Symptoms included nausea, vomiting, fatigue, cognitive issues, blood abnormalities, neuromuscular changes.
Danielle: That’s awful.
Simon: Surgeons would open up the joints and find black tissue and pockets of fluid filled with metal debris.
Danielle: Pockets of fluid... great.
Simon: The media called it one of the biggest disasters in orthopaedic history.
Danielle: Let me guess, they denied everything at first?
Simon: Of course. They claimed the ASR implants weren’t to blame. Said the recall was based on declining sales.
Danielle: Not safety?
Simon: Nope. But the real reason was that surgeons had already stopped using them. Word had spread. And the company had to pay for corrective surgeries, millions in compensation.
Danielle: Did anyone take them to court?
Simon: Yes. Many patients did. Some cases were lost, but others succeeded. Eventually, DePuy and Johnson & Johnson settled with a $2.5 billion payout.
Danielle: That’s massive.
Simon: It came down to the product being rushed through under that equivalency approval process. It changed the landscape of how medical devices are now regulated.
Danielle: And rightly so. You can’t experiment on tens of thousands of people.
Simon: Exactly. Testing a product by putting it on the market first is not okay.

Danielle: The corporate denial... followed by corporate regret.
Simon: Except businesses can’t really have a conscience. They’re just groups of people.
Danielle: True. But individuals within those companies must have known what was happening.
Simon: And still, sales teams were pushed to sell more, more, more. When they hit $1 billion in sales, they were told to aim for the next billion.
Danielle: That’s not shocking. It’s business.
Simon: Yeah, but it cost people their health. The NHS had to handle a lot of those corrective surgeries. Patients went through multiple operations.
Danielle: That’s huge strain on the system.
Simon: Thankfully, alternatives like ceramic and metal-plastic combinations are now standard. But still, many people have lasting health issues from those implants.
Danielle: And all from a hip.
Simon: You think about it now, how could they allow it to happen?
Danielle: Regulations weren’t strong enough.
Simon: But they are now, because of this.
Danielle: Well, that was a cheerful little tale.
Simon: You're welcome. Now hobble off and do something else.
Danielle: Cheers. Bye.