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.

The Stryker Rejuvenate and ABG II — Hip Stems That Corroded for $1.4 Billion

When Howmedica Osteonics, the orthopedic subsidiary of Stryker Corporation, posted an “Urgent Field Safety Notice” on July 3, 2012 withdrawing its Rejuvenate and ABG II modular-neck hip stems, the gap between the design’s selling point and its failure was already inscribed in the chemistry: the very feature marketed as an advance — a separable, surgeon-selectable metal neck joining the femoral stem at a second taper — was the site where the device destroyed itself. The stem was titanium alloy; the neck was cobalt-chromium. The two dissimilar metals, locked at a Morse taper and loaded with every step a patient took, fretted and corroded galvanically, shedding cobalt and chromium ions and metallic debris into the hip. Roughly 20,000 of the stems had been implanted before the recall.

The harm was not mechanical loosening of the kind orthopedics had long understood. It was a slow metallic poisoning of the joint. Released cobalt and chromium provoked adverse local tissue reactions — pseudotumors, fluid collections, and necrosis of muscle and bone — while systemic ion levels rose in the bloodstream, a condition clinicians call metallosis. Patients presented with pain, swelling, and instability; many were asymptomatic until imaging or blood testing revealed elevated metal levels and tissue destruction already underway. The remedy was rarely conservative. Revision surgery — extraction of a corroded, often well-fixed stem and replacement of the damaged joint — became the common endpoint, with its own attendant risks of fracture, infection, and permanent disability.

The Rejuvenate had reached the market not through clinical trials but through the FDA’s 510(k) pathway, cleared in June 2008 as “substantially equivalent” to predicate devices already on sale; the ABG II followed in November 2009. No premarket study had been required to prove that the modular junction was durable in living bodies. By July 2014 roughly 3,700 patients had sued. The litigation consolidated into a multidistrict proceeding in federal court in Minnesota and a coordinated docket before Judge Brian R. Martinotti in Bergen County, New Jersey, and on November 3, 2014 Stryker announced a settlement paying a base award of $300,000 per failed device removed, with enhancements for complications — a program that grew, through later expansions covering revisions into December 2016, to a payout exceeding $1.4 billion. The modular hip that promised the surgeon a custom fit became the textbook case of taper-junction corrosion and the limits of clearing an implant by analogy rather than evidence.