A new lawsuit indicates that Zimmer Biomet knew that its Kinectiv hip implant was defective by design but only considered profits rather than patient safety and continues to conceal substantial risk factors to the detriment of patients.
Sheryl Stode and her husband, James, filed the claim June 25 in the Middle District of Florida. The couple allege that the Zimmer Kinectiv Modular Neck System’s design causes excessive amounts of cobalt and chromium to wear and corrode, mainly where the modular metal neck snaps into the body of the femoral stem. This corrosion releases metal debris into the body, leading to serious complications. These complications include debilitating pain, metallosis, loosening, dislocation, and implant fracture. Furthermore, these toxic cobalt and chromium fragments cause the body to reject the hip implant, necessitating risky revision surgery to remove the device. These metal debris can also spread throughout the bone and tissue, causing severe inflammation, tumors, and other serious damage.
Zimmer Continues to Hide Kinectiv Hip Defects to Protect Profits at the Expense of Patients
Shortly after receiving FDA approval for the metal hip device, Zimmer began receiving complaints regarding patients who required revision surgery to remove and replace the Kinectiv Modular Neck System due to metallosis diagnoses and device failure. Reports of similar complications began flooding the FDA’s database, as well. Despite knowing that the Kinectiv Modular Neck System was defective and had failed many times, causing patients to undergo complicated, expensive, and painful revision surgeries with extensive recovery time, Zimmer continues to sell and promote the defective metal hip implant, while actively concealing its harmful defects from the public and medical community. Strode maintains that corporate greed motivated Zimmer to misrepresent the safety and efficacy of the Kinectiv hip system, protecting its bottom line at the peril of patients.
“Zimmer’s reason for concealing the defect in the Kinectiv Modular Neck System is clear,” the lawsuit states. “Hip implant sales are critically important to Zimmer, and the Kinectiv Modular Neck System is one of Zimmer’s more profitable products.”
“Zimmer chose corporate profits over patient safety,” the claim continues. “Rather than admit its Kinectiv Modular Neck System is defective… Zimmer continues to sell the defective Kinectiv Modular Neck System to unsuspecting patients without any warning about the risks or the failures reported to Zimmer.”
Kinectiv Hip Lawsuit
In October 2011, Strode underwent left hip replacement surgery. Relying on Zimmer’s misrepresentations of the Kinectiv hip implant’s efficacy and safety, her surgeon decided to use Zimmer’s Modular Neck System along with other Zimmer products.
Strodes’ Kinectiv Modular Neck System produced excessive trunnion wear with cobalt and chromium debris being released from interaction between the hip’s metal components. Consequently, hip implant quickly failed, causing severe pain. Since the Kinectiv hip uses a titanium neck, or stem, that connects to a cobalt and chrome femoral head, Strode experienced significant metal-on-metal wear that caused pseudotumor formation. Furthermore, her lab results should abnormally high carcinogenic cobalt levels.
In January 2016, Strode underwent revision surgery to remove the failed Zimmer Kinectiv hip system from her body as it was causing debilitating pain, metallosis, popping, and severe tendinitis. Since there is a reduced amount of bone to affix the new hip implant, revision surgeries are often more complex than the original hip replacement surgery. Revision surgeries also usually take longer than hip replacement surgeries and have a higher rate of complications.
A study by Brigham and Women’s Hospital in Boston showed that 14.4 percent of patients who had revision surgery suffered from a dislocation compared to 3.9 percent who had an original hip replacement surgery. Furthermore, surgeons couldn’t repair all the damage from the defective hip implant. Consequently, Strode still suffers from “severe and possibly permanent injuries.”
Proposed Zimmer Kinectiv Technology Multidistrict Litigation
As the number of Zimmer hip replacement lawsuits continues to grow over problems with the Zimmer M/L taper with Kinectiv Technology and the VerSys femoral head, plaintiffs are calling for the consolidation of all federal cases before one judge to maximize judicial efficiency.
Nearly two dozen plaintiffs filed the motion to transfer with the Judicial Panel on Multidistrict Litigation on June 19, indicating that district court cases should be transferred to Judge Donovan W. Frank in the District of Minnesota for coordinated management.
Given the similarities in the lawsuits over hip implant failure, pain, blood poisoning, tumors, and metallosis that are currently pending in about 10 different federal districts, plaintiffs argue that centralization is necessary to reduce duplicative discovery and conflicting pretrial rulings that could further delay the dissemination of justice.
“Movants allege in their complaints that the trunnion taper of the M/L Taper and Kinectiv femoral stems and the bore taper of the VerSys femoral head were defectively designed and/or manufactured, and promote fretting and corrosion at the junction between the femoral stem and the femoral head, resulting in personal injury and the need for revision surgery,” the motion states. “All of these cases seek damages against the same defendants based upon the same legal theories and operative facts.”
So far, the JPML has already centralized several litigations over similar hip designs into federal multidistrict litigations (MDLs). These include DePuy ASR, DePuy Pinnacle, Biomet Magnum, Wright Conserve, Stryker LFit v40, and Stryker Rejuvenate among others.
Metal-on-metal hip implants have become increasingly popular recently. However, recipients report high rates of failures and other serious issues that often necessitate revision surgery within a few years.
The JPML will likely hear oral arguments for the motion during a September 27, 2018, hearing in San Francisco, California.