In a regulatory filing this week, Wright Medical disclosed that they have received a federal subpoena for information relating to their Wright Profemur modular hip replacements, which comes as the company faces a number of lawsuits filed by individuals who had their implant fracture or break, as well as concerns about the safety of all modular neck hip replacement systems following a recent recall for a competing product that features a similar design.
According to a report filed with the Securities and Exchange Commission (SEC) this week, the Wright Medical disclosed that the U.S. Attorneys Office for the Western District of Tennessee has requested “records and documentation” from January 1, 2000 through August 2, 2012, involving their Profemur hip components.
The Wright Profemur Total Hip System is a line of artificial hip implants that feature a modular neck stem. Unlike most femoral components, modular neck stems consist of two parts that fit inside of each other, allowing the surgeon to adjust the component for leg length.
Although the manufacturer maintains that the U.S. Attorney’s subpoena is not an allegation of wrongdoing or any problems with Wright Profemur hip replacements, the request comes as the medical device manufacturer faces a number of product liability lawsuits over the device, were plaintiffs allege that the design makes the modular neck stem prone to fret, corrode, fracture or break.
In addition, concerns have increased in recent weeks that modular hips, which feature direct contact between the two metal parts that make up the femoral neck stem, may result in microscopic shavings of metal being released in to the body. This may cause problems with metallosis, which has been associated with traditional metal-on-metal hip replacements, and may cause the devices to loosen or fail prematurely.
Lawsuits Over Wright Profemur Neck Fractures and Other Problems
In the SEC filing, the manufacturer provided updated information about Wright Profemur hip lawsuits involving fractures of the titanium modular neck products. These lawsuits allege that the system features an unreasonably dangerous design, making the femoral stem likely to fracture, break, degrade fret and ultimately fail.
Although Wright claims that the overall Profemur fracture rate is low, and they believe that part of the problem is due to patient demographics, the manufacturer provided updated information about the potential liability stemming from these lawsuits in the SEC report.
An updated version of the Wright Profemur modular neck was introduced in 2010, and the company states that the lawsuits focus on the alternate titanium version, which Wright indicates may have lesser strength characteristics.
The company has estimated that their liability may be between $24 million and $39 million for lawsuits filed by individuals in North America who required a revision surgery following the fracture of a long Profemur titanium modular neck, or who may require revision in the future. The company has estimated that they will pay the majority of any settlements for Wright Profemur fractures within the next four years.
In addition to lawsuits involving the fractures of the Profemur stem, there are also a growing number of Wright metal-on-metal hip replacement lawsuits filed in state and federal courts throughout the United States, involving the company’s Conserve Plus Cup System, which features a metal femoral head rotating within a metal acetabular cup. Like similar lawsuits over other metal-on-metal hip systems, these complaints allege that Wright Medical knew or should have known about problems with the design, but continued to market the devices as safe and effective.
All federal Wright Conserve lawsuits have been consolidated for pretrial proceedings as part of an MDL, or multidistrict litigation, which is centralized in U.S. District Court for the Northern District of Georgia. In addition, there are a number of cases pending in various state courts.
Although the number of metal-on-metal lawsuits is increasing, Wright Medical maintains in the SEC filing that they believe data will support the “efficacy and safety” of their metal-on-metal hip products, and the company suggests that they plan to vigorously defend these cases.
Modular Hip Recall Causes Concerns for Wright Profemur
Concerns about the future sales potential for Wright Profemur hip replacement systems was also highlighted in the SEC filing, suggesting that a recent recall for a similar modular neck stem system issued by a competitor may cause doctors to back away from the Profemur hip implants.
In July 2012, a Stryker Rejuvenate and ABG II modular hip recall was issued, after that manufacturer indicated that their components may be prone to fret and corrode at the modular neck junction, which could cause pain, swelling, local tissue reactions and early failure of the hip replacement.
The Stryker Rejuvenate was approved by the FDA in 2010, and it was submitted as a substantially equivalent design to the Wright Profemur modular hip system, allowing Stryker to gain approval through the FDA’s 510(k) fast-track system because it was similar to the previously approved Profemur design.
The Wright Profemur was the first modular hip system introduced in the United States. Although the company transitioned from a titanium modular neck to a cobalt-chrome version of the Profemur in 2010, due to greater strength characteristics, the implant may face the same problems as the Stryker Rejuvenate, with corrosion and fretting as the metal parts of the modular hip make contact with each other.
In the SEC filing, Wright Medical acknowledges that the Stryker Rejuvenate recall, and the resulting publicity, may negatively impact sales of their modular neck systems. However, the company maintains that the modular hip stems differ in design and material, suggesting that the problems are unique to the Stryker products.