The DePuy ASR Hip — Metal Poisoning, a 2010 Recall, and $4 Billion

When DePuy Orthopaedics, the joint-replacement arm of Johnson & Johnson, recalled its Articular Surface Replacement (ASR) hip systems worldwide on 24 August 2010, the gap between the device’s promise and its harm was already legible in national arthroplasty registries: the ASR had been sold as a durable, large-diameter metal-on-metal joint suited to younger, more active patients, yet by the time of recall the company itself conceded a five-year revision rate near 13 percent — roughly one in eight — against an expected figure on the order of 5 percent, and independent registry follow-up would push the early-failure rate toward 40 percent within six years. Roughly 93,000 patients across the world had received one.

The mechanism was metallurgical, not surgical. The ASR paired a cobalt-chromium ball against a cobalt-chromium cup; in motion the two surfaces shed microscopic metal debris and released cobalt and chromium ions into surrounding tissue and the bloodstream. The local result was metallosis and adverse reaction to metal debris — soft-tissue necrosis, fluid-filled pseudotumors, and bone destruction that frequently demanded a second, more difficult operation. The systemic burden of circulating cobalt was linked in the literature to cardiac, neurological, and thyroid effects. The very design choice marketed as an advantage — a large bearing for stability — increased the surface area generating that debris, particularly when the shallow cup was implanted at a steep angle.

DePuy did not act on the first signal. The Australian Orthopaedic Association National Joint Replacement Registry identified an elevated revision rate for the ASR resurfacing system in 2007 and for the ASR XL acetabular system the following year, and conveyed the finding to the company in a series of reports. DePuy withdrew the ASR from Australia in 2009 citing “commercial reasons,” then continued selling it elsewhere until the 2010 global recall. In the United States, the ASR XL had reached market in 2008 through the FDA’s 510(k) clearance route — which permits sale on the basis of similarity to existing devices rather than fresh clinical proof of safety — while the resurfacing version was never approved for U.S. use at all. Litigation, not pre-market review, fixed the bill: J&J’s November 2013 U.S. settlement framework began at roughly $2.5 billion for about 8,000 revision claims and, with later expansions, grew past $4 billion as more than 11,000 plaintiffs came forward.