Zimmer Hip Mediation Result of Device Failure
Zimmer Inc.’s Metasul Durom Cup is the subject of mediation and lawsuits due to the device’s short-term failure rate and complications from the Zimmer hip. The product is most often used in young, healthy patients who are expected to outlive the lifespan of traditional hip replacement devices. As a metal-on-metal hip replacement, the Durom Cup is included in more than 5,000 consumer complaints that the FDA received in 2011 regarding this type of defective implant.
Durom Cup May Loosen, Causing Metal Poisoning
Problems with the Durom Cup hip replacement first emerged in 2008, when Dr. Larry Dorr reported that the product had a high failure rate, requiring patients to undergo Zimmer hip revision surgery. Dr. Dorr estimated that his patients had more than an 8% hip failure rate within two years of implantation – a number that, if applied to the 12,000 patients who had Durom Cup hip replacements by June 2008, calculated that almost 1,000 people would require revision surgery.
The major problem with the Durom Cup was product loosening, meaning that the implant separated from the hip and, in some cases, migrated a small distance. Patients experienced pain and, more seriously, a condition called metallosis, or metal poisoning. Metallosis is a condition that occurs when metallic particles from the hip implant are released into a patient’s bloodstream and travel to other organs. Symptoms of metallosis include rash, discomfort and pseudotumors – inflamed cells full of fluid, but which resemble tumors.
Patients experiencing metallosis and failed hip replacements were required to undergo revision surgery less than two years after first implantation. While the problem appears to be widespread, the device maker denied product malfunction and alleged that device failure resulted from improper implantation. Nevertheless, the company took its Metasul Durom Cup off the market for review in 2008. Later that year, the manufacturer rereleased the Durom Cup, which is still for sale as of October 2011.
FDA Looks for Solutions, Victims Explore Options
Due to thousands of complaints regarding metal-on-metal hip implant devices, the FDA has ordered reports from 21 leading orthopedic device manufacturers. The reports should outline the companies’ plans to follow-up on their devices and assure that they are working properly. The FDA has given the manufacturers one year to complete their reports.
In the meantime, hip replacement patients should first speak to their doctor or surgeon about pain or other symptoms. If you feel you have been a victim of a faulty hip replacement, do not sign any Zimmer release forms. Instead, contact a Zimmer hip attorney experienced in a hip replacement failure lawsuit to discuss legal recourse.Invalid tag specified, please contact administrator.
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