Federal regulators in the United States had serious safety concerns about one variation of a recalled DePuy hip implant. Johnson & Johnson nevertheless went ahead and sold thousands of the devices in Europe, before later acknowledging that all versions of the ASR hip implant may be prone to early failure.
According to a recent New York Times investigation, the FDA rejected the DePuy ASR Hip Resurfacing System after a detailed review of its safety profile raised concerns.
DePuy Orthopaedics, a division of Johnson & Johnson, was able to market the device in Europe without the concerns of U.S. regulators being relayed to their European counterparts.
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