Hip Device Phaseout By Johnson and Johnson After Food and Drug Administration Request

Johnson & Johnson executives decided in 2009 to phase out the hip implant and sell off its inventories for use in patients just weeks after the Food and Drug Administration asked the company in a letter for added safety data about the implant, administration documents and corporate records show, according to a recent New York Times Article.

The letter focused primarily on problems that agency reviewers found with study data submitted by DePuy to support its claim that the artificial hip was safe and effective.
The agency also asked DePuy for added safety data if it wanted to pursue its application.

The agency told the company that blood tests of some patients who got the all-metal hip showed a “high concentration of metal ions” that it found “concerning,” according to the Food and Drug Administration letter, obtained by The New York Times under the Freedom of Information Act