Thousands of people implanted with the ASR hip system have undergone ASR hip revision surgery sooner than they expected.

The ASR hip system was a hip joint prosthetic designed by DePuy Orthopaedics Inc., a subsidiary of Johnson and Johnson, that was cleared to market by the Food and Drug Administration (FDA) in August 2005.

The FDA cleared the medical device through its controversial fast-track 501K program.

DePuy claims on their website that they had had “clinical experience with other metal-on-metal products” prior to applying for clearance to justify their lack of clinical trials of the prosthetic. They also claim that they conducted numerous procedures to test the hip prosthetic units that included fretting, wear, deflection, materials, hip simulation, torque, lever-out, cadaver, and sawbones tests to name a few.

Nevertheless, the problems with the artificial joint mounted in patients requiring ASR hip revision surgery.

In August 2010, five years after approval, DePuy Orthopaedics made the decision to voluntarily recall all ASR and ASR XL hip systems. Again, according to the DePuy website, it was information gleaned in 2010 from the National Joint Registry of England and Wales that tipped the scales in favor of making this decision.

The information passed on was that many recipients of the prosthetic were having to undergo early ASR hip revision surgery with total removal of the artificial joint in favor of another prosthetic choice.

The FDA 501K clearance system is controversial because a pharmaceutical or medical device company just has to prove “substantial equivalence” to a like drug or device on the market. It bypasses all the standard array of clinical trials that are typically necessary to get these items available commercially.

While the fast-tracked system is beneficial in that it cuts through red tape that might hinder necessary and vital medical devices from reaching people, it also is problematic in that people often have to suffer, sometimes catastrophically, before issues are discovered with the marketed drugs or devices.

In the case of ASR hip systems, thousands of total hip arthroscopy patients had to undergo second invasive procedures to remove the implant after much pain and suffering.

Because of the number of people having to undergo ASR hip revision surgery, DePuy Orthopaedics decided to make a settlement outside of court. This settlement was divided into sections. The first section was dated November 2013. It was slated to compensate patients who had their ASR hip prosthetics removed and replaced prior to Aug. 31, 2013.

The second section of the settlement was dated March 2015. It was slated to compensate patients who had had to undergo ASR hip revision surgery between Aug. 31, 2013 and Jan. 31, 2015. The third section was really an extension of the second. It was dated March of this year and extends the previous end date of ASR hip revision surgery to Feb. 15, 2017.

If you feel you have been hurt because of a faulty hip prosthetic implant, a product liability lawyer can offer a free consultation to see if you can receive compensation for your pain and suffering.