A terrifying statistic for the many thousands of patients who have undergone hip replacement surgery appeared in a Bloomberg article published in June of this year. The article explained that the FDA reported some 16,800 adverse events related to metal-on-metal hip implants in the U.S. between 2000 and 2011.
Another company is under the spotlight as the quality and durability of their products are in question. The Wright Medical Profemur Total Hip System is a line of hip replacement implants designed and manufactured by Wright Medical Technology. Problems have been reported with the device along the same lines of other all-metal counterparts.
One lawsuit was filed by a Michigan man in late 2011 which says the patient’s Wright Profemur hip replacement failed less than three years after implantation, leading to severe problems. Other similar lawsuits have been filed against the manufacturer, each alleging the design of the Wright Profemur Hip Replacement Implant is defective and prone to early failure. The fact that these hip implant systems may fail within a few years after surgery is bad because it results in additional hip revision surgery, a painful process that no patient should be subjected to a second time in such a short period.
Hip implants should last for at least 15 years, but data indicates that the Wright Profemur Hip Implant often fails within just a few years of implantation. For example, 2009 data from an implant registry run by the Australian Orthopaedic Association found that one component, the Wright Profemur Z femoral stem, shows an 11.2% failure rate at the three-year interval. This means that approximately one out of every 9 people who received the Wright Profemur Z hip implant experienced severe problems within a few years after their hip replacement.
Like so many other medical devices that have gone on to cause trouble for unsuspecting patients, the Wright Profemur Total Hip System was approved by the U.S. Food & Drug Administration (FDA) under its 510(k) clearance protocols. A 510(k) approval is permitted for devices that are substantially equivalent to devices already on the market. Unfortunately, 510(k) approvals do not require human clinical trials, so problems caused by devices approved this way often do not become apparent until they have been on the market for several years.
Kobs & Philley, PLLC is now accepting metal-on-metal hip implant injury cases. If you have been injured and have questions about your rights, do not hesitate to contact Kobs & Philley, PLLC today.
Source: “FDA reports 16,800 Adverse Events Linked to Metal-on-Metal Hip Implants,” published at TimesUnion.com.
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