Stryker must face a personal injury Trident hip implant lawsuit, a Massachusetts federal judge has ruled.
Stryker sought to avoid the lawsuit, brought over its Trident hip implant device, arguing that the case asserts a so-called “parallel claim that is not pre-empted under federal law, said the federal judge. The plaintiffs allege that Stryker was negligent in the way in which it made and distributed the Trident hip, said MassDevice, citing court documents. Stryker moved to dismiss the lawsuit, arguing preemption; however, Judge Patty Saris dismissed the motion. The plaintiffs also said that Stryker neglected to follow Current Good Manufacturing Practice regulations (CGMP).
The plaintiffs brought the class action on behalf of all Massachusetts residents who “have undergone total hip arthroplasty since 2003 using the defendants’ Trident System containing Trident Hemispherical Acetabular Shells, and who have experienced a failure of said Trident System” that may include “an audible ‘squeaking’ emanating from the replaced hip joint area; pain and/or discomfort in the replaced hip joint area; and/or the necessity for revision surgery of the replaced hip joint,” said court documents, according to MassDevice.
The Stryker Trident was recalled in 2008 when a probe revealed “deviations between specifications and processes for manufacturing required by the FDA whereby, among other failures, excessive bioburden and manufacturing residuals were found in the final rinse tank thereby contaminating the devices,” according to the lawsuit, said MassDevice.
In these cases, one plaintiff, who underwent double hip replacement with the Trident, required revision surgeries for both hips in 2012. Court documents, said Mass Device, described the Trident Systems as becoming “grossly loose” due to bone ingrowth that was inhibited on the devices over contamination due to the defendants not complying with agency standards and mandates, according to the complaint, wrote MassDevice.
We previously wrote about research that found that liner dissociation has been seen in devices with alternative bearings such as Stryker’s Trident Tripolar Constrained Liner, Zimmer’s Harris-Galante Porous I and II acetabular components and its Metasul® Metal-on-Metal Liners, and DePuy Orthopaedic’s Pinnacle. The devices are constructed with a polyethylene liner and an acetabular shell. Liner and shell separation was seen in cases involving patients who underwent a primary total hip arthroplasty with the device’s acetabular component. In each case studied, patients had to undergo revision surgery to remove and replace defective components.
Surgery involved polyethylene liners which are meant to increase femoral head coverage and is meant to allow for larger femoral heads with smaller cup diameters, which should provide improved stability with no impingement risks, explained The Journal of Bone and Joint Surgery previously. These components are constructed to increase hip motion and stability and should, theoretically, enable surgeons to make fine adjustments to the device during surgery.
In the cases studied, direct trauma was not involved and, in every case, patients reported squeaking sounds from the area of the implant. The Journal of Bone and Joint Surgery pointed out that when the removed liners were examined, plastic deformation of the polyethylene liner rim was seen. Two patients said they suffered from nonlocalized hip pain; surgery revealed signs of metal transfer to the ceramic head and signs of metallosis in the joint.
The defect involved a failure of the locking mechanism that is meant to secure the polyethylene liner to the metal acetabular shell. The weak locking mechanism can lead to liner deformation, rim wear, and implant dissociation and failure.