Imagine that you had hip replacement surgery only to discover that your new, all-metal hip had been recalled. That is the nightmare facing virtually 30,000 patients right now in the U.S., leading to thousands of medical malpractice lawsuits.

The real issue in this case is that the hip manufacturer appears to have withheld the findings in a Food & Drug Administration (FDA) report about safety issues with the hip. This happened long before the recall.

A Johnson & Johnson subsidiary, DePuy Orthopaedics, made a decision not to publicize the agency’s findings to doctors, patients and others while it continued to market the device. That fact may undercut its defense related to 5,000 lawsuits pending against it. The company’s reputation could also be severely damaged.

DePuy has blamed orthopedic surgeons for the hip’s failures. They accused the doctors of failing to position the component properly. The irony is that the data shows the studies using the model hip were run by surgeons hand-picked by DePuy. Some of them had even helped develop the implant and received royalties and fees in connection with it.

A year before it recalled the artificial hip, Johnson & Johnson stated in an internal email that the FDA had refused to approve the device because it had failed prematurely in “significant” numbers. Patients with the implants had to undergo repeated surgeries.

The statement in that email contrasted with those the company had previously made, in which it maintained that the device was safe. The device the FDA turned down was sold only overseas, but a similar version had already been used on 30,000 patients.

To win FDA approval, a device like the DePuy hip must be proven to be safe and effective. That can be done by showing that it is at least as effective as, or not inferior to, a traditional hip implant.

Most artificial hips last 15 years or more. When they wear out, they need to be replaced. By 2008, data from orthopedic databases abroad showed that the DePuy metal hip was failing in patients after just a few years. In addition, the hip also sometimes sheds metallic debris, and those particles have severely damaged tissue in some patients.

Even without full FDA approval, DePuy used a regulatory loophole in 2005 to start marketing a version of the implant in the U.S. Both the version sold overseas and the one used here utilized the same key component. This solid metal cup replaced a patient’s hip socket. That cup was flawed in design, experts say.

In 2009, DePuy began to backpedal on marketing the device. They blamed declining sales on that decision rather than safety issues.