Tuesday, February 12, 2013

How Stryker Corrosion Lawyers Can Help

An Overview of Stryker Neck Hip Stems

When the Stryker Rejuvenate hip implant was introduced it was considered quite innovative in design; the Rejuvenate was marketed in 2009 after gaining FDA approval in June, 2008. While traditional hip implant designs were manufactured with a one piece neck and stem, both the Rejuvenate and ABGII have a design which implements a variety of components. In fact, the ABGII hip implant has sixteen stems—including left and right sides, and ten different sizes of modular neck. Six stems and sixteen necks make up the Rejuvenate hip implant system. Marketing for the Rejuvenate claimed that this hip implant was designed specifically for the younger, more active patient who was currently experiencing limited mobility of their hip joint.

The variety of modular necks and stems gave surgeons many more choices when implanting the hip system as they were able to more closely match the hip implant to the specific body type and activity level of the individual patient. The Rejuvenate and ABGII were also meant to last much longer than the traditional ceramic or polyethylene hip implants which had been the norm until the metal implants were marketed. Unfortunately, only a short time after the Rejuvenate and ABGII hip implants began being used, adverse reports from implant recipients began coming in to the FDA. When the hip device was surgically implanted into the hip region, the stem and neck rubbed against one another any time the patient engaged in physical activities. This resulted in fretting and corrosion which in turn led to metallosis and metal toxicity among recipients of these two Stryker hip implants.

How Stryker Corrosion Can Damage Your Health

Although the Rejuvenate and ABGII are not considered “true” metal-on-metal hip implants, the necks are made of cobalt and chromium and the stems are titanium-coated. There is also a metal-on-metal junction, meaning the ABGII and Rejuvenate are both subject to many of the same risks of metal toxicity and metallosis as the all-metal hip implants. Additionally, small metal trunnions are located on either end of the neck piece, allowing it to snap into place between the stem and the head. Body fluids can become trapped beneath these trunnions, leading to corrosion and the same issues as the metal shear which results from the all-metal hip implant although on a bit of a smaller scale.

Symptoms of Metallosis Resulting From Stryker Corrosion

When corrosion occurs, cobalt and chromium ions are released into the body; when they become lodged in the hip tissues, inflammation, tissue necrosis and bone loss are possible. Should these issues occur, it is likely the hip implant will fail as the surrounding tissues loosen, leading to a necessary revision surgery. Should the metal ions gain access to the bloodstream, symptoms of metal toxicity may begin to emerge including: neurological, cardiovascular, renal and thyroid issues, vision and hearing loss, DNA disruption, gastrointestinal disorders, skin rashes, vertigo, memory loss, anxiety, depression and irritability.

Why You Should Consider a Stryker Corrosion Lawsuit

Stryker Corporation generates over $8 billion dollars in annual sales across the globe with a large amount of that coming from the sales of their hip implants. The Rejuvenate gained FDA approval in 2008 while the ABGII was approved in 2009. Both hip implants gained approval through the controversial 510(k) approval process. This means both hip implants were marketed without benefit of human testing because DePuy could claim their device was substantially equivalent to a device which had already been approved. Because product safety was not required to be tested prior to implanting the devices in human patients, the flaws were only discovered after the implants had been placed into thousands of human beings. Stryker issued a recall for the ABGII and the Rejuvenate this past July, 2012. The recall came on the heels of a safety alert sent out the prior April which stated both models had the potential of fretting and corrosion which could damage the health of recipients. Lawyers around the nation are gearing up to file numerous lawsuits which are expected following the recall. Attorneys who work in the product liability area understand the many complexities of such lawsuits. 

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