Posted in News on February 28, 2014
As people in Montana age, bone density changes, and for many hip and knee replacement may become necessary. Today, such replacement surgery is a routine surgical procedure, and various orthopedic devices are used. In the United States, the Food and Drug Administration is in charge of ensuring the safety of medical and surgical products. In spite of the FDA’s regulatory oversight, the orthopedic device company Zimmer was sued recently by a woman who alleged that a hip replacement system the company made caused her significant injuries and pain when it shattered.
According to legal paperwork filed by the woman, she underwent hip replacement surgery in 2008, and had a Zimmer product called Trilogy AB implanted. The woman claimed that four years after the operation, she sensed a crunching sensation in her left hip after a misstep during a shopping trip overseas, despite the fact that she hadn’t fallen. An X-ray of her hip indicated that her artificial hip has shattered. The woman returned to the United States to undergo additional surgery to replace the shattered ceramic hip liner.
In her lawsuit against Zimmer, the woman alleged that because of the faulty product, and in order to remove the defective product, she had to endure expensive and painful revision surgery. Furthermore, as a result of the all this, she suffered significant injuries which directly impacted her ability to care for herself, and caused her permanent injuries.
Even though the FDA approved the specific product in question, in 2012 one of the company’s manufacturing facilities was found to be in violation of many FDA requirements. Additionally, multiple problems with the Trilogy system, such as cracked liners, were reported back to the FDA in 2011. In fact, the woman’s surgeon also reported problems with this particular hip replacement device in other patients.
As a result of the injuries and harm caused to her by the faulty product, the woman is seeking compensation for medical expenses, pain and suffering, loss of earning and more. Hopefully, this case will remind medical device manufacturers and regulators of the importance of quality control to the medical device industry.
Source: StaceyPageOnline.com, “Zimmer Facing Another Faulty Product Lawsuit,” John Faulkner, Feb. 21, 2014