Thursday, June 16, 2011

FDA Investigates Metal Poisoning from Zimmer Hip Replacements

As concerns grow about the levels of cobalt and chromium shed by metal on metal hip replacement devices, the FDA is ordering manufacturers to conduct followup research on patients to see what health effects the implants may have. In all, FDA sent a total of 145 post marketing surveillance orders to 21 different manufacturers including Zimmer. When completed, the studies will include information about the level at which the metal particles shed by hip replacements becomes dangerous, how much metal the devices actually shed, and what the potential side effects are. It is known that over time, metal particles around some implants can lead to damage to bone and/or tissue around the implant or joint. This damage is referred to by some as an "adverse local tissue reaction (ALTR)" or an "adverse reaction to metal debris (ARMD)." Many patients are experiencing Zimmer hip implant failure and need a revision surgery.

According to the FDA, all artificial hip implant systems pose potential risks associated with implant or material wear. Metal-on-metal hip replacement systems are known especially to have unique risks in addition the basic risks of all hip implant systems. Since the metal ball and the metal cup slide against each other when an individual walks or runs, it is possible for tiny metal particles to wear off of the hip implant device and enter into the space around the implant. When this happens, some of the metal ions from the metal implant or from the metal particles can make their way into a person's bloodstream. Failed implants require Zimmer hip revision surgery, which is a lengthy, painful process.

Many metal-on-metal hip replacements have been linked to a high rate of early failure. In July 2008, a Zimmer Hip recall was issued for more than 12,000 of the metal hip implants, after it was discovered that a higher-than-expected number were failing within a few years of surgery. Similar problems have been reported in connection with other metal-on-metal hip implants sold by other companies. Common signs that a hip replacement system, like the ones manufactured by Zimmer and others, may not be functioning accurately include swelling at or near the hip joint; pain or discomfort in the hip, leg, or groin; and, a limp or change in walking capability. Victims suffering from Zimmer hip failure are advised to consult with an experienced Zimmer hip lawyer as soon as possible.

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