Arterial blood gas, Australia, Food & Drug Administration, Health, Hip Replacement, Medicine, metal, science, Stryker, Therapeutic Goods Administration, UNited States
Stryker Encourages Monitoring of Australian Rejuvenate and ABG II Hip Recipients – February 25, 2013.
The July 2012 recall of Stryker Rejuvenate and ABG II hip replacement devices has affected recipients worldwide, prompting government health agencies in various countries to issue directives to encourage citizens who have been implanted with the company’s devices to undergo regular monitoring.
According to an article published on February 20, 2013, on the medical device industry news Web site, MassDevice.com, Australia’s Therapeutic Goods Administration (a government agency similar to the U.S. Food and Drug Administration) has issued a set of guidelines in conjunction with Stryker’s Australian division, advising recipients of the recalled hip replacements to be mindful of symptoms that could be associated with failure of the devices.
Guidelines Recommend Regular Follow-Up
The guidelines recommend regular blood testing and imaging for asymptomatic patients, as well as additional follow-up and evaluation if symptoms of failure are present. If testing reveals evidence of increased levels of metals in the blood, revision surgery might be necessary to explant and replace the defective Stryker hip.
The recommendations were issued because the Therapeutic Goods Administration continues to receive reports that an increasing number of hip replacement recipients patients are being diagnosed with soft tissue injuries in addition to elevated levels of metal in the blood. At least one patient who developed symptoms shortly after an initial evaluation turned out to have both increased levels of metal ions in the blood, and soft tissue damage, according to the MassDevice article.
The United States, and other countries in addition to Australia, have also suggested that hip replacement recipients remain vigilant and undergo regular screening for symptoms of device failure. While pain and swelling of the hip are obvious concerns, many patients might not experience symptoms associated with elevated metal levels in the blood, and should undergo regular testing, even if they are not experiencing any other symptoms.
Stryker recalled the Rejuvenate and ABG II hip implants because of high failure rates brought on by fretting and corrosion of the device components. These hip replacements were originally intended to provide orthopedic surgeons with the ability to provide patients with a better fit, along with greater mobility and flexibility. Unfortunately, the Stryker devices proved problematic, along with other metal-on-metal hip replacement devices manufactured by other companies.
The Rottenstein Law Group Helps Patients Who Have Been Injured by Recalled Stryker Hips
It is important to consult your orthopedic surgeon to determine whether the symptoms you might be experiencing are consistent with a failed hip replacement and if that implant was manufactured and sold by Stryker.
Lawsuits are currently being filed across the country by recipients of the recalled Stryker implants. Plaintiffs are seeking compensation for pain and suffering, unforeseen medical expenses, lost wages, and other claims. The lawyers at the Rottenstein Law Group have over 25 years of collective experience advocating for individuals who have been harmed by dangerous drugs and defective medical devices. If you feel you have reason to sue Stryker, fill out our confidential contact form or call 1-888-224-9712 for a free case evaluation. One of our lawyers will be in touch with you shortly.
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