FDA Announces New Device ID System to Improve Patient Safety in Wake of Stryker Recall
The U.S. Food and Drug Administration (FDA)’s new medical device identification system will allow federal regulators to keep track of products on the market with greater efficiency, and may better target problems with high-risk products similar to those affected by the Stryker hip recall, the agency announced in September.
According to an update posted September 20th on the FDA’s website, the unique device identification (UDI) system will require all medical device manufacturers to equip each of their products with a unique number indicating its model, expiration date and manufacturing date. The agency plans to phase in the new program with high-risk medical devices, which may include metal hip replacements like the now-recalled Stryker Rejuvenate and ABG II modular-neck hip stems. The new program will also improve the specificity and accuracy of adverse event reports associated with certain devices, which may allow the FDA to more quickly issue recalls and improve patient safety.
Individuals Affected by Stryker Recall Allege Metallosis, Early Hip Failure Complications
Unfortunately, the launch of this program was announced more than a year after individuals affected by the Stryker hip recall began filing lawsuits by the dozens after allegedly suffering pain, swelling, metallosis and other side effects. According to hundreds of cases filed in the U.S., multiple revision surgeries are often necessary to remove the implant in the event that early hip failure complications are experienced.
Approximately 20,000 Stryker Rejuvenate and ABG II hip devices were sold in the U.S. prior to July 6, 2012, when the manufacturer announced its artificial hip recall.
More than a year later, court records indicate that a total of 290 Stryker recall lawsuits have been filed in a federal litigation underway in the U.S. District Court, District of Minnesota, while 382 cases are currently pending in a consolidated proceeding established in New Jersey’s Bergen County Superior Court. Plaintiffs involved in these litigations similarly allege that the recalled modular-neck hip stems were designed defectively by Stryker Orthopaedics, who also failed to warn consumers about their potential to fail prematurely and cause complications.
Conversely, thousands of individuals have been affected by other metal hip implant recalls in the U.S. Court records indicate that some 11,000 DePuy ASR lawsuit claims have been filed over the DePuy Orthopaedics-manufactured ASR metal-on-metal hip replacement, and thousands more have been brought over a version of the DePuy Pinnacle device that includes a metal Ultamet liner.
Call a Lawyer at Bernstein Liebhard LLP to File a Stryker Lawsuit
If you received the Stryker Rejuvenate or ABG II modular-neck hip stem and experienced complications, call an attorney at our Firm to file a case at (877) 779-1414.