During the first week of August 2012, a 66-year old woman from Florida filed a Stryker hip replacement lawsuit in the Bergen County superior court. She sought compensation for the defective Rejuvenate hip replacement components which gave her a number of serious health complications. The plaintiff underwent hip replacement on her right hip in October 2011. Months after the surgery, she felt severe pain and her blood samples showed she had high levels of metal caused by the Stryker Rejuvenate modular hip system. In June 2012, her doctor advised her to undergo revision surgery to remove the abnormal tissue growth near her right hip. The plaintiff needs more surgeries to correct her health problems.
On July 2012, Stryker recalled its ABG II neck stems and Rejuvenate Modular hip implant stems. The reason for its market recall was stated as “potential fretting and/or corrosion at or about the modular-neck junction, which may result in adverse local tissue reactions manifesting with pain and/or swelling.” Stryker Orthopedics leads the worldwide market for hip replacement parts, but patients implanted with the metal hip systems have been diagnosed with metallosis or metal poisoning. Many experienced a sharp rise in cobalt and chromium levels. Cobalt and chromium is what makes up the Rejuvenate modular hip implant. Aside from the cobalt and chromium stem, the neck is made of titanium. The FDA received 60 complaints against Stryker’s Rejuvenate modular hip implant from January to July 2012.
The metal parts of the Rejuvenate implant rub against each other when a person does normal day-to-day activities. The hip implant’s defective design is the main reason of metallosis and the devices’ failure. Aside from metal poisoning, complaints on the Rejuvenate hip device include infection, bone necrosis, pseudotumor formation, and abnormal tissue formation. The most highlighted drawback of the Stryker Rejuvenate hip device is that the company never conducted safety trials on the product before its introduction in February 2010. Stryker Orthopedics sought the FDA’s approval through the agency’s 510(k) clearance program. The program approves any product that has a substantial equivalent sold in the market and the Rejuvenate and ABG II were said to be akin to the Wright Profemur hip implants.
The FDA warned Stryker Orthopedics about their devices twice. In November 2007, a FDA team visited a Stryker facility in New Jersey and discovered clusters of Staphylococcus bacteria throughout the plant. Before the Rejuvenate and ABG II neck stems were manufactured, Stryker had already pulled out two products in 2008: the Trident Hemispherical and Acetabular PSL Cups. Unfortunately, when the company recalled their products, several patients have already filed their respective Stryker hip replacement lawsuit. According to Forbes, manufacturers of metal hip implants may cost an estimated $5 billion with 30,000 lawsuits in the coming years.
On July 2012, Stryker recalled its ABG II neck stems and Rejuvenate Modular hip implant stems. The reason for its market recall was stated as “potential fretting and/or corrosion at or about the modular-neck junction, which may result in adverse local tissue reactions manifesting with pain and/or swelling.” Stryker Orthopedics leads the worldwide market for hip replacement parts, but patients implanted with the metal hip systems have been diagnosed with metallosis or metal poisoning. Many experienced a sharp rise in cobalt and chromium levels. Cobalt and chromium is what makes up the Rejuvenate modular hip implant. Aside from the cobalt and chromium stem, the neck is made of titanium. The FDA received 60 complaints against Stryker’s Rejuvenate modular hip implant from January to July 2012.
The metal parts of the Rejuvenate implant rub against each other when a person does normal day-to-day activities. The hip implant’s defective design is the main reason of metallosis and the devices’ failure. Aside from metal poisoning, complaints on the Rejuvenate hip device include infection, bone necrosis, pseudotumor formation, and abnormal tissue formation. The most highlighted drawback of the Stryker Rejuvenate hip device is that the company never conducted safety trials on the product before its introduction in February 2010. Stryker Orthopedics sought the FDA’s approval through the agency’s 510(k) clearance program. The program approves any product that has a substantial equivalent sold in the market and the Rejuvenate and ABG II were said to be akin to the Wright Profemur hip implants.
The FDA warned Stryker Orthopedics about their devices twice. In November 2007, a FDA team visited a Stryker facility in New Jersey and discovered clusters of Staphylococcus bacteria throughout the plant. Before the Rejuvenate and ABG II neck stems were manufactured, Stryker had already pulled out two products in 2008: the Trident Hemispherical and Acetabular PSL Cups. Unfortunately, when the company recalled their products, several patients have already filed their respective Stryker hip replacement lawsuit. According to Forbes, manufacturers of metal hip implants may cost an estimated $5 billion with 30,000 lawsuits in the coming years.
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