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Top 5 Types of Bad Medical Devices: Knee Replacements

Top 5 Types of Bad Medical Devices: Knee Replacements

Top 5 Types of Bad Medical Devices: Knee Replacements

Each year, more than 600,000 knee replacements are performed in the United States, according to the American Academy of Orthopaedic Surgeons. Many of these devices are implanted due to osteoarthritis, which causes the cartilage of the knee to wear away over time. As a result, the bones of the knee joint can rub together and lead to painful bone spurs. Knee replacements are intended to offer relief, but most physicians look into other alternatives before considering this surgery.

More than 700 recalls have been issued for knee implants among five manufacturers. Thousands of lawsuits have been filed against these device makers, including DePuy Orthopedics, Zimmer Holdings, Biomet, Smith & Nephew, and Stryker Orthopedics. All surgical procedures carry some risk of side effects or complications. The knee implant lawsuits mostly allege that patients suffered from more serious injuries due to the defectively designed or manufactured device. A number of patients are suing because they had to undergo revision surgery to remove the failed implant.

Serious complications associated with knee implants include severe pain or inflammation, infection that may spread to the rest of the body, damage to nerves or blood vessel surrounding the implant, damage to bone or joint, implant loosening and blood clots in the lower leg.

Parker Waichman LLP represents numerous individuals in lawsuits over medical device injuries. If you or someone you know suffered complications related to knee replacements, contact our firm today for more information about your legal rights.

Most knee replacements were approved through the U.S. Food and Drug Administration’s (FDA’s) 510(k) program, which does not require traditional clinical trials for safety and efficacy. Through this route, devices can be placed on the market without these restrictions so long as the manufacturer can prove that the product is “substantially equivalent” to an older product.

A recent knee replacement recall was issued in March 2015. Zimmer recalled a component of its Persona implant, the Trabecular Metal Tibial Plate, due to “an increase in complaints of radiolucent lines and loosening.” The recall was designated as Class II.

DePuy, a subsidiary of Johnson & Johnson, is one of the biggest manufacturers of joint replacements worldwide. The company manufactures its High-Flex knee implants: the Sigma CR150 High-Flex Knee System and the Sigma RP-F Knee System. In 2008, a mislabeling issue prompted DePuy to recall its LCS Knee Implant-Meniscal bearing insert. An international recall was issued in 2009 for its LCS Duofix Femoral Component; this part was not approved in the United States, however.

Smith & Nephew recalled its Journey Uni Tibial Baseplate knee implant of roughly 40,000 units in 2010. The recall was issued following reports that the base plates could break. If this component is broken, it can result in instability and, ultimately, the need for revision surgery. This issue was highlighted at an annual meeting of the American Academy of Orthopaedic Surgeons in 2011, when researchers presented a study showing that the Smith & Nephew Journey Deuce knee implants failed at a rate of 16 percent in only 21 months. Smith & Nephew also recalled its Oxinium Genesis II and Oxinium Profix II in 2003 due to reports of high revision rates and complications. In 2008, the company recalled its TC-PLUS, VKS and RT-PLUS because iron levels in the devices were higher than indicated.

Stryker Orthopedics recalled 26,000 EIUS Unicompartmental Knee Systems in January 2012. The recall was issued following reports of high failure rates. Several years before the recall, the FDA warned the company about procedural problems at two of its facilities. The agency cited the Duracon and Scorpio components, along with others, in its letters.

Parker Waichman LLP offers free, no-obligation legal consultations to individuals who suffered injuries and complications related to knee implants. If your or someone you know has any questions about filing a lawsuits over total knee replacements, contact Parker Waichman LLP today.

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