DePuy Orthopedics, now a subsidiary of Johnson & Johnson, developed and manufactured the DePuy ASR™ XL Acetabular System and the ASR™ Hip Resurfacing System. Instead of obtaining the more rigorous FDA Premarket Approval, DePuy was able to start marketing the ASR XL in 2005 via what was called 510(k) Clearance. In short, hip manufacturers were able to obtain 510(k) clearances for devices that bore similarities to other devices the FDA had earlier approved through the Premarket Approval instead of obtaining a new approval for this new device. The FDA has since closed this loophole for metal-on-metal hip implants.
Failures and Injuries Lead to a Recall
In the years after its launch, problems with the ASR began to develop with patients developing excessive metal debris, metallosis, adverse location tissue reaction, pain, inflammation, and failure of the implant, ultimately requiring a revision surgery. Ultimately, DePuy would recall the ASR in August 2010, but not before 93,000 people were implanted with the device, one-third of whom lived in the United States. While hip implants are typically expected to last 15 years or more, now-public internal DePuy documents would show that DePuy knew the ASR was failing in a high rate of patients in only a few years, but failed to take public action until the August 2010 recall.
Following the recall, lawsuits ensued with cases in federal court consolidated for pre-trial purposes in the United States District Court for the Northern District of Ohio. Plaintiffs also filed a number of cases in various state courts. Ultimately, DePuy agreed to a multi-billion-dollar settlement with some plaintiffs in 2013. Another settlement agreement was reached in 2015 and the 2015 agreement was extended in 2017 to additional qualifying claimants.
Understanding the DePuy ASR
Hip replacement surgery is a procedure that replaces a worn out joint with an artificial replacement. Modern hip implant replacement technology typically involves one of two types of surgeries: a total hip replacement and a resurfacing. Total hip replacement involves multiple components, including the femoral stem, femoral neck, and, the femoral head. A hip resurfacing is a more conservative surgery that preserves more of the patient’s bone, but is less common. Which procedure a patient undergoes depends on factors such as the patient’s age, gender and bone condition. By developing ASR products for both total hip replacement and resurfacing, DePuy sought to provide options for the entire hip market. Unfortunately, the ASR would be marketed in the United States for only five years before it was recalled.
ASR Failure Symptoms
When the DePuy ASR fails, a variety of problems can occur. Potential hazards include:
- metal corrosion
- excessive metal debris
- metallosis (metal debris released into the nearby tissue and bone)
- adverse location tissue reaction
- loss of mobility
- implant failure requiring a revision surgery
Have You Suffered Due to Implantation of a DePuy ASR Device?
If you had a DePuy ASR hip implanted and have had to undergo a revision surgery or anticipate having to undergo a revision surgery you need to speak with an experienced medical device attorney as soon as possible. Please contact us online or call us directly at 318.541.8188 to schedule a free consultation.