February 28, 2013
New safety guidelines recommend closer and more attentive safety monitoring for patients fitted with recalled Stryker Corp. hip implant systems, even for those who have yet to experience pain or other related symptoms.
The hip implants in question — Stryker’s ABG II and Rejuvenate modular-neck hip stem systems — were voluntarily recalled after post-market surveillance revealed incidences of pain and soft-tissue damage, which requires revision surgery to replace the faulty device.
In an Urgent Safety Alert issued in April 2012, Stryker warned physicians of fretting and corrosion complications with the metal-on-metal components of these hip systems. While Stryker’s revolutionary interchangeable neck stems allow surgeons to more accurately recreate a patient’s natural hip structure, metal corrosion was found to cause serious complications in a subset of patients.
As the implant’s components rub together during normal use, metal particles can erode from the device causing pain, inflammation and other harmful reactions. In July 2012, Stryker recalled the products and halted the global production of both systems.
Stryker Australia Revises Monitoring Guidelines
Stryker’s defective hip implants have injured patients worldwide, prompting medical device regulators to call for more vigilant oversight.
Since the July 2012 recall, Australian regulators have identified asymptomatic patients who suffer from soft-tissue injuries and at least one patient with soft-tissue damage and heightened levels of metal ions in the blood. This condition, known as metallosis, is directly caused by debris shed from the implant.
When Stryker’s Australian branch sent updated patient monitoring guidelines to national health regulators, the country’s Therapeutic Goods Administration advised frequent blood testing and cross-sectional imaging scans for all patients fitted with Rejuvenate or ABG II hip systems.
In initial warnings, Stryker recommended that surgeons continue their normal routine for patient monitoring unless the patient reported pain or swelling that could result from implant wear.
Post-Market Surveillance Continues
The Food and Drug Administration (FDA) has received at least 60 adverse event reports of metal toxicity that led to revision surgeries. In an FDA press release discussing the recall, Stryker says “the decision to voluntarily remove Rejuvenate and ABG II modular-neck stems and terminate global distribution of these products comes after continued post-market surveillance,” and warns that “the post-market surveillance data may be predictive of a trend.”
While the FDA has yet to make an official statement advising all patients fitted with a defective implant to contact their surgeons for blood testing and imaging scans, Stryker’s website suggests they contact their surgeons for an evaluation. “It is important,” says Stryker, “that you follow up with your surgeon, even if you are not experiencing symptoms such as pain and/or swelling at or around your hip.”
After an evaluation, surgeons may order blood tests or imaging scans like X-rays or CT scans to help determine the next course of action.
Stryker Down, but Not Out
In January 2013, Stryker estimated that the 2012 hip implant recall could cost the company up to $390 million between patient testing and treatment, revision surgeries, insurance payments and lawsuits.
To help manage claims filed by patients affected by the recall, Stryker hired Broadspire Services, a third-party claims administrator that handled similar complications with DePuy’s ASR hip implant, which was recalled back in 2010.
Despite a growing number of hip implant lawsuits, last month Stryker reported improved sales of its hip, knee and spine products. With an 11.8 percent rise in earnings compared with last year, Stryker saw fourth-quarter earnings of $436 million.