File this story under: exporting your problems.

That’s what Johnson & Johnson did after the FDA said the company wasn’t allowed to market its artificial hip in the U.S. because J&J’s own studies showed the device was unsafe.

As recounted in the New York Times, not only did J&J pawn its questionable product off on Europeans, it continued to sell a related model in the U.S. that had been made available temporarily only because of a regulatory loophole enabling it to escape the scrutiny of a safety review. In December 2010, The Times called that device “[o]ne of the most troubled orthopedic implants of the past decade.”

It’s not known how many people overseas got the banished replacement hip after the FDA failed to approve it in 2009, nor how many U.S. patients got the similar implant. The two were on the market for eight years and implanted in about 93,000 patients worldwide; about one-third of them were in the U.S.

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