Johnson & Johnson wrote internal emails in 2009, one year before recalling the device that the FDA refused to approve it after noting it was failing prematurely in “significant” numbers, requiring repeat surgeries to replace it [reported by the New York Times @ www.nytimes.com].
This type of medical device should last for approximately 15 years. During this time the company maintained publically that it was safe. The company also used a regulatory loophole in 2005 to start marketing a version of this device, with its flawed design, for use in hip replacement surgeries, not just resurfacing procedures. This, in spite of the fact that the company knew the FDA previously rejected the resurfacing version of the device.