FDA Warns Stryker Corporation about Defective Hip Implants
In 2007, the Stryker Corporation was investigated and ultimately warned by the Food and Drug Administration about a series of problems with its Trident Hemispherical and Trident PSL hip implant models. Following the FDAs actions, Stryker issued a recall of each product in early 2008. This article explains the FDAs investigation, and the warning letters sent to Stryker that led to the 2008 hip implant recall. For an article about the 2012 Stryker hip implant recall, click here.
The FDA Investigates Stryker in 2007
The FDAs investigation, conducted from June 1st through July 12th 2007, uncovered problems relating to Strykers Trident hip-replacement systems. According to the FDA, consumers have complained about the products defects and have had to undergo further surgeries. However, Stryker has done little to correct the problems. The FDAs investigation revealed the following complaints:
- January of 2005 through May of 2007: Trident Hemispherical and Trident PSL cups failed to function; hip implant components have poor fixation. In some instances, these problems have required revision surgeries.
- January of 2005 through April of 2007: Squeaking noises of hip implants with ceramic bearing components; some of those problems resulted in revision surgeries due to implant failures (fractures, pain, wear particles, and fragments).
- January of 2005 through June of 2007: Improper seating of hip implants in broached bones resulting in bone fractures.
According to the Food and Drug Administration (FDA), Stryker was aware of customer complaints about its Trident line of ceramic-on-ceramic hip implant products since 2005.
Medical Studies Supporting the FDA
At least three prominent doctors confirmed much of the data the FDA relied on. These doctors expressed serious concern about ceramic-on-ceramic implant products in 2006. The following findings were public and available to Stryker before the company issued its recall:
- At a conference in late 2006, at which many of the orthopedic surgeons around the country and world convened to talk about various issues, problems and technologies, discussion about the squeaking phenomenon surfaced during several podium speeches and creating a fire-storm of discussion. At this meeting, Dr. Christopher Jarrett raised the issue of ceramic-on-ceramic Trident devices resulting in audible noises or squeaks. Other doctors at the conference reported having the same experience with their patients.
- Coinciding almost exactly with this late 2006 conference, Italian surgeon Toni Aldo published a study entitled Early Diagnosis of Ceramic Liner Fracture in the Journal of Bone and Joint Surgery in late 2006. The study concluded that cup component enhanced the risk of impingement and the liner fractures. It revealed that squeaks from ceramic total hips were likely to be a precursor to hip failure and advised that early diagnosis of a ceramic liner fracture is desirable to avoid a wide spread of ceramic particles in the periarticular space (the space surrounding a joint).
The FDA found that Stryker knew about the issues that were discovered by these and other physicians, but did not take any corrective action. In a letter released on January 15th of 2008, the FDA warned Stryker to address the issues concerning these products.
The FDAs Warning to Stryker
In 2008, the FDA sent a warning letter to Stryker accusing the company of quality and compliance deficiencies including falsifying hospital approval documents, having inadequate procedures for clinical studies and also criticized the company for how device reports and product complaints were handled.
The FDA concluded that Stryker failed to implement adequate corrective and preventive actions (which would include verifying or validating the corrective and preventive action to ensure that such action is effective) in order to prevent the recurrence of nonconforming product and other quality problems. It was clear to the FDA that Stryker knew, or should have known, about the problems that patients were experiencing with their Trident hip implants as early as 2005.
In 2009 the U.S. Attorney's Office for the District of Massachusetts completed an investigation into Stryker's questionable business practices and has returned an indictment charging Stryker Biotech LLC and certain of its current and former employees with wire fraud, conspiracy to defraud the FDA, distribution of a misbranded device and for making false statements to the FDA. If the company is found guilty of the charges, it could be barred from participating in federal and state healthcare programs and face huge fines.
The FDAs investigation that demonstrated a failure to respond to concerns about its implants has proven to be significant in lawsuits against Stryker. If you, or anyone you know, has been injured by a Stryker hip implant that was part of the 2008 recall, contact an attorney immediately. For a free, no obligation consultation with a qualified attorney, please click here.