Two prominent Chicago orthopedic surgeons are calling for the recall of Zimmer’s NexGen CR-Flex Knee replacement devices. There has already been a recall of related devices to a part of the knee.
The porous femoral component (that is, the part of the replacement that covers the head of the femur, the bone that goes from the pelvis to the knee) is associated with a high rate of failure. The two Chicago surgeons calling for the Zimmer recall, Richard Berger and Craig Della Valle from Rush University Medical Center, have observed after two years’ of use that 36% of the implants were loose, and 9.3% were revised or set to be revised because of looseness and associated pain.
The doctors stated that “This component is still commercially available but should not be used for any patient.” They also questioned the fact that the product was released for sale to the public without clinical testing. Dr. Berger described the failure rate as “horrific.”
Dr. Berger has contacted Zimmer but observes that they have not been receptive to his concerns.
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What Happened?
The Zimmer NexGen Knee Replacement lawsuit involves claims that the NexGen knee implants manufactured by Zimmer, Inc. were defective and caused injuries to patients who received them.
The NexGen knee replacement system was first approved by the U.S. Food and Drug Administration (FDA) in 2001, and it was marketed as a more advanced and durable alternative to previous knee replacement systems. However, soon after the product was introduced to the market, reports of complications began to emerge.
The Zimmer NexGen MIS Tibial component was made for use with the CR-Flex Knee. The MIS Tibial component is generally utilized in less invasive procedures. These doctors tend to shoot for a small incision as opposed to the sometimes foot-long cuts that would occur with traditional replacement surgery. If this can be done, it is better for the patients. Smaller scar, less blood loss, and shorter recovery time.
Concerns Raised Immediately
But pretty quickly we started hearing of unacceptably high failure rates with the MIS Tibial Component. Zimmer responded by issuing a recall, admitting that the MIS Tibial Component design has inherent challenges that made it harder for the surgeon to see what she was doing during surgery. Obviously, a doctor needs to have good visibility during surgery because it can cause a host of problems, specifically, in knee replacements, difficulty in getting the right implant alignment that is properly secured.
Patients who received the NexGen knee replacement system reported a range of serious complications, including premature implant failure, loosening of the implant, and metal poisoning due to the release of metal particles from the implant into the surrounding tissue.
Many patients who received the implant required revision surgery to replace the failed implant, and some suffered permanent disability or disfigurement as a result of the complications.
Zimmer Recall
In response to the growing number of complaints, the FDA issued a Class 2 recall of the NexGen MIS Tibial Component in 2010 due to concerns over high failure rates. Zimmer later voluntarily recalled certain lots of the NexGen Complete Knee Solution MIS Tibial Components in 2015.
Zimmer Lawsuits
Lawsuits were filed against Zimmer by patients who had received the NexGen knee replacement system and suffered complications. In 2011, the U.S. Judicial Panel on Multidistrict Litigation (JPML) consolidated all federal lawsuits involving Zimmer NexGen knee implants into a single multidistrict litigation (MDL) in the Northern District of Illinois. At that time, there were 18 lawsuits pending against Zimmer in various federal courts across the country.
The plaintiffs alleged that Zimmer knew or should have known about the risks associated with the implant and failed to adequately warn patients and doctors of the potential dangers.
Zimmer Class Action
In 2015, a federal judge in Illinois consolidated more than 1,000 lawsuits against Zimmer into a multidistrict litigation (MDL) proceeding. The MDL allowed the cases to be coordinated and streamlined to more efficiently manage pretrial proceedings. We call it a “class action lawsuit.”
One bellwether case when to trial which Zimmer won. A second bellwether trial was settled out of court.
Zimmer Settlement
In 2016, did something few defendants do: they quit while they were ahead. Zimmer reached a settlement agreement in the MDL to resolve the majority of the claims against the company. Under the terms of the settlement, Zimmer agreed to pay $314 million to settle approximately 1,300 cases.
Zimmer Lawsuit Status as of 2023
The settlement did not include all of the claims against Zimmer, and some cases continued to be litigated in courts around the country. As of 2023, there were still some active cases involving the NexGen knee replacement system pending in various state and federal courts.