Archive for the ‘FDA Recall’ Category
Zimmer Recalls 40,000 Knee Implant Devices
July 28th, 2014 at 7:00 am
Knee replacements have long been one of the most common surgical implants. They are also one of the most common procedures in which patients experience subsequent problems because the device used was defective or not up to safety standards (though approved by the Food and Drug Administration (FDA)).
According to a consumer report from SafePatientProject.org, 4.4 million Americans have knee implants, the vast majority of which were prescribed for osteoarthritis of the knee. Regardless of how many such procedures are undergone every year in the U.S., replacement surgeries continue to be a serious factor in the medical industry. Reported by the SafePatientProject, “an estimated 536,000 adults currently living with knee implants have undergone revision procedures to replace their implants.”
It is not as if the implants that needed to be replaced were manufactured by smaller or lesser-known companies. Biomet, DePuy, Smith & Nephew, Stryker, Wright, and Zimmer have all recalled knee implants that were used in patient surgery and that had previously been approved by the FDA. As of September 2103, DePuy had the most recalls, and Zimmer was a close second.
This July, however, Zimmer manufacturing “initiated another sweeping recall on one of its artificial knee implants,” according to DrugWatch.com. Noted by DrugWatch, the NexGen MIS Tibial Component is being recalled because of the tendency of the pieces to loosen or fail. There is no other explanation being offered other than shoddy manufacturing.
No matter the reason, more than 40,000 of these devices have been recalled, affecting thousands of patients nationwide. If a patient does not have the device removed, he or she may face side effects that include (but are not limited to):
- Bone loss;
- Early revision surgery;
- Infection; and
- Dislocation.
In the event of bone loss, infection, or dislocation, some patients could actually end up worse off than they were before the initial implant surgery.
If you or someone you know has had a Zimmer knee implant surgery performed in Connecticut, do not go through it alone. Contact Richard H. Raphael, Attorney at Law, an experienced Connecticut medical malpractice attorney, for a free initial consultation today.
Unsterile Medications Recalled
February 21st, 2014 at 12:00 pm
In late December, Abrams Royal, a compounding pharmacy based in Texas, voluntarily recalled all products produced at its Dallas plant meant for sterile use, according to a Food and Drug Administration (FDA) press release. “Recalled products include injectable medications, intravenous (IV) injections, eye drops, pellet implants, nasal sprays, inhalation solutions, and eye ointments that were distributed between June 17, 2013 and December 17, 2013,” the FDA reports. Because these products are meant for sterile use, patients who come into contact with them face serious risk of infection or injury.
Abrams was made aware of the situation after just one adverse event. A patient in California who received a mineral IV injection “had blood cultures that tested positive for Stenotrophomonas maltophilia, a gram-negative bacterium that can cause many types of infection,” according to the FDA. Such infections range from pneumonia to meningitis.
Howard Skalmberg, director of the Office of Compliance at the FDA said in the statement that patient safety is the agency’s top priority. “Using these products puts patients at an unacceptable risk,” Skalmberg said, “and we urge health care professionals to follow recall instructions issued by the firm.”
It’s not just unsterile medications, such as those recalled by Abrams, which cause infections in the hospital, however. Dr. Peter Pronovost, director of the Quality and Safety Research Group at Johns Hopkins told CNN that about 100,000 people die every year from infections they receive at the hospital. “Take the two most deadly types of infections hospitals give their patients: infections from ventilators and infections from catheters. Together, those kill 65,000 people a year,” he said.
If you or someone you know has been infected while at the hospital in Connecticut—either from faulty or unsterile medications, such as what has been recalled by Abrams, or because of hospital conditions—the most important step is to seek legal counsel. Don’t go through it alone. Contact Richard H. Raphael, Attorney at Law, today.