Am I affected?
DePuy Orthopaedics (a company owned by Johnson & Johnson) has been in the news recently because it issued a worldwide recall of two hip replacement devices that it manufactured. If you had a hip replaced in the past several years, you might be concerned that this DePuy recall affects you. The information on this page is designed to help you understand what, exactly, is going on, and whether or not you need to do anything.
The units being recalled are the ASR XL Acetabular System and the ASR Hip Resurfacing System. Due to a faulty design of metal-on-metal moving parts, both of these units have the ability to shed into the recipient’s body toxic metal fragments that can produce serious side effects, including:
- Pain and swelling
- Difficulty walking
- ALVAL (asceptic lymphocyte-dominated vasculitis associated lesion) and pseudotumors
- Dislocation of the joint
- Bone fractures around the implant
Because of these risks, many patients with an implanted ASR device need what Johnson & Johnson is calling a “revision” surgery—that is, a second surgery to remove and replace a faulty, and dangerous, ASR unit.
Both the Acetabular System and the Hip Resurfacing System first became available in July 2003. Therefore, if you had hip replacement surgery prior to this, then your replacement hip is not subject to this recall. If you’ve had hip replacement surgery after July 2003, however, then there is a possibility that you received a recalled ASR device.
The only way to find out for sure whether your replacement hip is one being recalled is to speak with your orthopedic surgeon (or your general practitioner, if he or she has your full medical history). It is possible that you will not need additional surgery even if your received an ASR device. Your doctor(s) will perform an evaluation and discuss with you whether you are at risk of developing dangerous health problems because of your ASR device. It is important that you consult your doctor even if you are not experiencing any pain, swelling, or difficulty walking.
Johnson & Johnson has pledged to cover the “reasonable and customary costs of monitoring and treatment.” This means you should be reimbursed for the costs of the necessary tests to determine your safety, as well as the cost of revision surgery, if it is necessary. If you have any questions, you can contact DePuy toll-free at 888-627-2677 or visit the official website of the ASR hip system recall.