Last month Styker Othropedics announced that it was recalling its Rejuvenate and ABG II Modular-Neck Hip Implant Systems and discontinuing global production of the implant systems. As we reported, the Stryker hip implants were recalled due to risks of corrosion and fretting which can damage or injure surrounding tissues. Patients whose hip implants have experienced corrosion and/or fretting may suffer pain and/or swelling at the local joint site.
Stryker recalled both of these hip implant systems because the metal of the neck and stem can corrode, causing toxic metal ions to be released into the body, which can damage tissue and bones around the hip implant resulting in severe pain, inflammation, metal poisoning (metallosis from chromium and cobalt), tissue death (necrosis), bone damage, pseudotumers, gait issues, and other serious problems. Subsequent corrective surgery to remove and replace the recalled Stryker hip product may be required.
The Stryker ABG II modular-neck stem
The Stryker ABG II modular-neck stem is a multi-piece hip replacement system that was intended to be compatible with each patient’s unique biomechanics by using interchangeable parts. The Stryker ABG II is technically a plastic-on-ceramic hip implant, but the hip implant uses a metal-on-metal neck/stem joint. Like other metal-on-metal hip implants, including the DePuy ASR, which was recalled in 2010, the Stryker ABG II received swift FDA approval through the 510(k) approval process. Pursuant to the 510(k) approval process, the FDA allows manufacturers to avoid conducting long-term safety studies of new devices as long as they are “substantially similar” to existing devices.
Stryker ABG II Recall
In May 2012, Stryker warned orthopedic surgeons of the following risks associated with the ABG II hip implant:
- Excessive corrosion at the neck joint, which could shed toxic particles into the patient’s body
- Pain, inflammation, tissue damage, and swelling caused by toxic metal particles
- Allergic reaction, especially in patients with metal sensitivity
- Osteolysis (dissolving bone loss) caused by metal particles
What to Do If You Have Received One of the Recalled Hip Implants
Patients who have received the recalled Styker hip implants should consult with their doctor immediately. If you are uncertain about whether you have one of the recalled products implant, you should also contact your doctor or consult your medical records. A patient call center has been established and patients can call (888) 317-0200 or visit www.AboutStryker.com/ModularNeckStems for additional information.
If you suspect that your hip implant system is causing medical problems, such as swelling or pain, you should see your doctor immediately. You may also wish to consult with a skilled hip implant attorney as you may be entitled to compensation for injuries, including medical expenses, lost wages, and pain and suffering, in a product liability or medical malpractice lawsuit. Contact the Chicago product liability lawyers at Ankin Law Offices, LLC at (312) 600-0000 to learn more about the Stryker hip implant recall.