Orthopedic devices giant Stryker announced recall of 2 hip implants over concerns that the devices may be prone to "fretting and/or corrosion at or about the modular-neck junction," which may lead to pain, swelling and adverse reactions in surrounding tissue. Read the FDA Safety WARNING HERE.
The recall affects the company's Rejuvenate Modular and ABG II modular-neck hip stems, and Stryker decided to terminate global production of the devices after discovering a potential trend in post-market surveillance data.
The Stryker Rejuvenate hip replacement device has been linked to an increased risk of metallosis. Although the Stryker Rejuvenate is not a metal-on-metal hip device, it has metal-on-metal components, which are believed to be responsible for the development of metallosis in some patients. According to reports, the Stryker Rejuvenate hip implant device is linked to a high early failure rate, resulting in some patients having revision surgery to replace their hip replacement device.
What is a Modular Neck stem?
Modular neck stems allow physicians to more accurately reproduce a patient's natural hip geometry and "can facilitate femoral component insertion in more technically challenging surgical approaches," according to a Stryker report dated 2012. It was marketed to younger patients as a modular hip replacement, meaning the components were custom-made to fit patients better, which was supposed to result in longer-lasting hip replacement devices that offered a better range of motion.
Some patients reportedly developed metallosis after having the Stryker Rejuvenate hip device implanted. Although it was initially believed that such a condition was not possible, because the Stryker Rejuvenate does not have a metal on metal ball and socket design, the Stryker hip device has a metal neck piece that can rub against a metal stem, causing metallic debris to come loose.
Stryker Metallosis Problems
The neck stems have also been associated with metallosis arising from metal corrosion. The company recently released a report which outlines that they may exhibit the same metallosis issues plaguing metal-on-metal artificial hips.
"In vivo production of metal debris from implants has been the subject of much scrutiny recently. Metal on metal bearings, for example, produce small (20-80nm diameter) metallic wear debris whenever motion is present," the report noted. "Elevated blood serum metal ion levels (it is believed these metal ions are produced by corrosion of the wear debris in the case of metal on metal joints) and metal hypersensitivity resulting in an adverse local tissue reaction may occur with metal-metal articular surface bearings, causing premature failure due to osteolysis, aseptic loosening and in some instances a devastating pseudotumor formation."
"It has been shown that a similar reaction and potentially premature failure of the total hip arthroplasty may occur in rare cases of patients with both modular head and modular-neck femoral components," according to the report .
Frequently Answered Questions from the Stryker website:
Q: Why are these products being voluntarily withdrawn from the market?
A: While modular neck hip stems provide surgeons with an option to correct certain aspects of a patient’s anatomy and hip biomechanics, we decided to voluntarily recall these modular-neck stem hip systems because there is a potential for fretting and corrosion at the modular-neck junction which may lead to adverse local tissue reactions.
Q: How would I know if my hip implant is experiencing fretting and corrosion?
A: The incidence of complications associated with modular-neck stems is extremely low. Affected patients may present with symptoms of pain and/or swelling at the local joint site not attributable to other conditions, such as aseptic loosening and periprosthetic sepsis. Patients experiencing pain and/or swelling should speak with their surgeon.
Q: What should I do if I have one of these hips but don’t have any pain or swelling?
A: If you have no symptoms, you should continue to follow the post-operative plan that your surgeon has outlined for you. If you have further questions, please contact the call center at 1-888-317-0200 (U.S. and Canada only).
Q: I have pain and/or swelling around my hip now. What should I do?
A: If you have symptoms of pain and/or swelling in or around your replaced hip, you should schedule an office visit with your surgeon to discuss your symptoms. If you have further questions, please contact the call center at 1-888-317-0200 (U.S. and Canada only).
Q: Is there a chance this issue will affect me in the future if I don't have any symptoms now?
A: The incidence of complications associated with modular-neck stems is extremely low. If in the future you experience pain and/or swelling of the hip, you should schedule an office visit with your surgeon to discuss your symptoms.
Q: I have a Rejuvenate Modular or ABG II Modular implant. Do I need revision surgery?
A: The incidence of complications associated with modular neck stems is extremely low. Affected patients may present with symptoms of pain and swelling at the local joint site not attributable to other conditions such as aseptic loosening and periprosthetic sepsis. Patients experiencing pain and/or swelling should speak with their surgeon.
Q: I don't know if I have Rejuvenate or ABG II, how can I find out?
A: For privacy reasons patients should speak with their surgeons and/or review their medical records for implant identification information.
Q: I don't have Rejuvenate or ABG II, but I do have a Stryker hip. Should I be concerned?
A: This voluntary recall is specific to Rejuvenate Modular and ABG II modular-neck stems only.
Shezad Malik is an Internal Medicine and Cardiology specialist, a licensed Texas Medical Doctor and Defective Medical Device and Dangerous Drug Attorney. Dr Shezad Malik Law Firm has offices based in Fort Worth and Dallas and represents people who have suffered catastrophic and serious personal injuries including wrongful death, caused by the negligence or recklessness of others.