Stryker Hip Replacement
In July 2012, approximately 20,000 Stryker hip stem replacement devices were affected by a voluntarily recall issued by the manufacturer. Since then, more and more patients who underwent hip replacement surgeries involving the Stryker Rejuvenate and ABG II modular-neck hip stems claim to have experienced complications stemming from the implants.
Many of those patients have come forward to file claims against Stryker Orthopaedics seeking compensation for medical expenses, lost wages, pain and suffering and other damages incurred by their injuries. If you suffered pain, swelling, inflammation, symptoms of metallosis or other injuries, you may be eligible to file a claim against the manufacturer. Learn more about your legal rights, and how to file a lawsuit over the recalled Stryker hip replacements by contacting an attorney at Bernstein Liebhard LLP today at .
Stryker Hip Replacement Side Effects
Issued on July 6, 2012, the Stryker hip recall was prompted by company data findings that indicated the potential for metal components of the device to fret and/or corrode, which may cause adverse tissue reactions and possibly metallosis (metal ion poisoning).
The following side effects have been associated with the Stryker Rejuvenate and ABG II modular-neck hip stems:
- pain and/or swelling at the local joint site;
- immobility; and
- inflammation of the surrounding tissue.
Adverse tissue reactions stemming from the affected Stryker hip replacement devices may also manifest in the formation of pseudotumors, necrosis (premature tissue death), osteolysis (bone dissolution) and other injuries.
Prior to the announcement of the Stryker hip recall, the U.S. Food and Drug Administration (FDA) received approximately 60 adverse event reports stemming from use of the modular-neck hip stems. All of those complaints named metal toxicity requiring revision surgery.
History of the Rejuvenate, ABG II Stryker Hip Replacement
According to Drugwatch.com, the Stryker Rejuvenate received FDA approval in June 2008, while the ABG II system was granted approval in November 2009. Both modular-neck hip stems were then introduced in 2009 after being designed to provide surgeons with greater flexibility in their ability to be custom-fitted to patients.
It is noteworthy to add that these Stryker hip replacements were approved by the FDA via its 510(k) process, which allows a product to bypass clinical testing if the manufacturer can prove it to be substantially equivalent to one already on the market. That means the company was only required to conduct post-market surveillance, which may be the reason why Stryker only became aware of the potentially dangerous complications suggested to stem from its devices after the fact.
Several metal-on-metal hip replacement devices, including the now-recalled DePuy ASR metal-on-metal hip replacement were approved via the 510(k) program. This device, which was recalled in August 2010, has been named in thousands of adverse event reports indicating early hip failure in patients. 93,000 implants were affected by the DePuy ASR hip recall.
Prompted by the growing concerns over the safety and effectiveness of metal-on-metal hips, the FDA proposed new regulations in January 2013 that would require all metal implants to undergo pre-market clinical testing before they could receive approval. This would make this class of devices ineligible to enter the market through the agency’s 510(k) process.
How to File a Stryker Hip Replacement Lawsuit
If you experienced pain, swelling, inflammation, and other side effects related to early hip failure, you may be eligible to file a Stryker hip replacement lawsuit against the manufacturer. Claims filed against Stryker seek compensation for medical bills, lost wages, pain and suffering and other damages caused by the patient’s injury. To find out more, contact an attorney at Bernstein Liebhard LLP at .