A personal injury lawsuit has been filed against Zimmer Inc., described as the largest producer of orthopedic devices in the United States. James Cabral claims he suffered constant and devastating pain for over 18 months and requires a second hip replacement surgery because of an allegedly defective implant manufactured and sold by Zimmer under the brand name Durom Cup.
The Durom Cup was first sold in the U.S. in 2006 and has been implanted in more than 12,000 patients in just two years. The complaint estimates that the deviceâ€™s failure rate, to date, is between 20 and 30 percent; however, that figure is expected to increase as the device continues to fail over time. â€œMy life as I had known it up until my hip replacement surgery has wholly changed,â€ said James Cabral, 57, said in a statement announcing the suit. â€œI use to lead a very active lifestyle, playing sports, traveling, and keeping up with my grandchildren, but my limited range of motion and the physical pain now make these activities impossible. I am still able to work, fortunately, but not without pain and I often use a cane for support,â€ added Cabral.
In July 2008, six months after Cabral received his Durom Cup, Zimmer issued a “temporary suspension” of sales due to the unacceptable failure rate. It seems that the device does not urge bone growth, as it should, and loosens, even popping free from the hip, said Cabralâ€™s attorney. This defect is known to result in significant pain and surgery to remove the defective device and replace it with a different device. The Durom Cup, a “metal-on-metal” implant, is meant to bond to the existing hipbone and is neither cemented nor screwed into the bone.
After introduction in United States, Zimmer began receiving complaints from physicians that its Durom Cup was failing; however, Zimmer continued its marketing of the device in 2007 and 2008, saying that surgeons were to blame. Finally, in 2008, the device maker temporarily suspended Durom Cup sales in the U.S. while it updated its labeling to better inform surgeons on the device and its instructions, as well as training. Meanwhile, Zimmer refuses to issue a recall and clams there is no â€œevidence of defect.â€
Meanwhile, we recently wrote that a prominent surgeon, once a consultant for Zimmer Holdings, believes the company likely terminated their consulting relationship with him because he questioned the performance of another of its artificial joints, this one, a knee. According to The New York Times, Dr. Richard A. Berger alleged that a version of Zimmerâ€™s NexGen CR-Flex artificial knee is prone to premature failure.
According to the Times, by 2006, X-rays of some of Dr. Bergerâ€™s patients indicated that the device was loose and had not fused completely. Patients were reporting pain, a result of the loose joint. Dr. Berger reported the problems to Zimmer, but Zimmer pointed to the deviceâ€™s success. According to the Times, Zimmer did not have separate test data on the un-cemented model because the U.S. Food & Drug Administration (FDA) had not required the company to study it in patients before selling it.
We also wrote that the million or so artificial hips and knees implanted each year in the U.S. donâ€™t come with any type of guarantee or warranty, instead, according to another New York Times article, when a device fails, the cost is borne by Medicareâ€”which translates into taxpayer costsâ€”insurance companies, and patients. At about $15,000 per implant, the cost to the healthcare system is huge, even if only a small percentage of implants fail because of a defect. Even worse, some device makers may actually profit when an implant fails. In many cases, the manufacturer of the defective implant provides the replacementâ€”at full price.