In early September, DePuy Orthopaedics, Inc., a subsidiary of Johnson & Johnson, recalled two models of hip implants. The two products subject to this recall are the ASR XL Acetabular system, which is a hip socket used in traditional hip replacement, and the ASR Hip Resurfacing System, which is a partial hip replacement involving the placement of a metal cap on the ball of the femur. According to DePuy spokeswoman Lorie Gawreluk, 93,000 of these devices have been used in implants globally.
The Food and Drug Administration actually began receiving complaints about the DePuy Orthopaedics hip implants in 2006. In August of 2010, the FDA sent a warning leatter to DePuy Orthopaedics advising the company that it was marketing products without the necessary and required clearance or approval, in violation of the Federal Food, Drug, and Cosmetic Act. In that same letter, the FDA noted that, “a review of our records reveals that you have not obtained marketing approval or clearance before you began offering the TruMatch Personalized Solutions System for sale, which is a violation of the law.”
According to a New York Times article, in 2008, the FDA began receiving complaints, now totaling over 400, from patients in the United States who had received the now-recalled DePuy devices. Those devices, which are part of a category of implants called metal-on-metal bearings, came under scrutiny since the bearings can generate debris from wear which in turn causes inflammation and damage for certain patients.
DePuy, on its website, provides a number of recommendations for patients who have received the ASR XL Acetabular system or the ASR Hip Resurfacing System:
- Make an appointment with your surgeon to evaluate how your ASR Hip System is functioning
- In the event that you experience pain, difficulty walking, or other symptoms, your surgeon may take x-rays of your hip. These x-rays enable the surgeon to evaluate the positioning of the ASR Hip System, determine whether it has remained attached properly, and assess any potential damage to the bone. Depending on the x-rays, your surgeon may recommend a surgery to replace the implant
- Your surgeon may order additional blood testing or imaging to ensure the proper functioning of your ASR Hip System
- The blood testing may involve assessing the level of microscopic metal particles around your hip. If the test indicates a high level of these particles, your surgeon may recommend a follow-up test three months later. The blood tests are important because they may indicate high levels of metal particles even if you are not experiencing any identifiable symptoms.
- If a second blood test still indicates high levels of metal particles, your surgeon may order an MRI or ultrasound test of your ASR Hip System. Depending on the outcome of these tests, your surgeon might recommend a second surgery to replace your implant, which is a decision you and your surgeon need to discuss fully in light of your own personal health needs.
- In the event that you do not experience any symptoms and test results do not indicate an immediate concern, you should continue to follow your surgeon’s recommendations with regard to ongoing monitoring and follow-up.
- If you do need to have an additional surgery, there are various options available to you and your surgeon will aid in selecting the appropriate implant system for you.
If you or a loved one has received the DePuy ASR XL Acetabular System or DePuy ASR Hip Resurfacing System and have experienced some type of hip pain, additional hip surgery, or some type of failure with your hip replacement, you may want to contact CSS Firm for a free case evaluation and consultation. Our experienced team of defective hip implant lawyers will work closely with you and see to it that you are compensated for your injuries.
A partner with Childers, Schlueter & Smith, LLC,, Brandon Smith has devoted his practice to pharmaceutical litigation, mass torts, products liability and serious personal injury. A frequent guest speaker at legal seminars all over the country—Brandon is focused on helping injured victims nationwide, however possible. Named a SuperLawyer in 2017, he has also been called out as one of 10 Best Attorneys For Georgia by the American Institute Of Personal Injury Attorneys.