Zimmer replacement knees danger to patients.Currently, nearly 60,000 people have knee replacements annually. There are many potential side effects and dangers can arise anytime someone goes under the knife. Complications can occur from infections and other medical issues. Surgeons must the possible discuss side effects and complications with their patients and obtain their patients’ informed consent to perform the surgery. A patient must endure a long, harrowing, and difficult course of rehabilitation and strengthening before regaining normal and pain-free use of the repaired knee. The last thing a knee replacement patient wants is to have to undergo a second surgery to replace defective hardware in the knee. However, many knee replacement patients must face that cruel reality due to faulty components of the artificial knee.
Knee Surgery and Its Complications
Knee replacement surgery is a significant operation. Surgeons must remove the old, damaged knee, repair and debride as must of the organic tissue as possible, and then seat the artificial knee. Knee replacements surgery involves moving and tearing the muscles, tendons, ligaments, and vascular structures of the knee. The potential for permanent damageis doubled when the joint manufacturer produces an inferior or defective device requiring the surgeon to remove the first replacement knee and insert a second knee.
Aside from the muscle damage, many potential life-threatening complications can arise during surgery. Infection is the most common concern. Heart attacks, stroke, and nerve damage are other medical issues that surgeons guard against.In addition, a patient could have blood clotting issues which necessitate taking a prescription like Pradaxa or Xarelto, both of which come with their own potential side effects. There is also the possibility of an adverse reaction to the anesthesia. Furthermore, post-operation pain control is concerning. Doctors continue to prescribe powerful, opiate-based painkillers that can result in becoming addicted to the medicine in the worst case scenario but also cause significant discomfort from opiate induced constipation.
FDA Approval Process for Zimmer’s Persona Knee Replacement System
Zimmer’s NextGen “Persona Personalized Knee System” has caused numerous problems since the U.S. Food and Drug Administration (FDA) approved the prosthetic for human use. Zimmer raced the device through 510(k) premarket registration instead of going through the typical FDA approval process or being tested by traditional clinical trials. The FDA approved Zimmer’s application without limitation or hesitation, finding that all components functioned as intended by Zimmer and were safe. The FDA dated announced its approval of Zimmer’s 510(k) application in March of 2012.
Section 510(k) of the Food, Drug, and Cosmetic Act relieves some medical device manufacturers of proving that their medical devices are safe and perform as intended by the manufacturer because the device is similar to those previously marketed. Additionally, appropriate labeling and packaging must accompany the device, the producer completes and files the correct paperwork with the FDA, and the manufacturer has a quality control system approved by the FDA.
The FDA approved the knee for all appropriate uses under its authority under Section 510(k). Zimmer stated that its Persona prosthetic would provide a new surface for the three bones, femur, tibia, and patellar, that form a human knee joint along with a prosthetic knee joint. Zimmer described the replacement knee joint as “modular” and would fit within the bones of the knee.
Zimmer designated a class of patients for it Persona knee replacement system. In particular, Zimmer indicated that the device was intended for people suffering from “severe pain and disability” as a result of:
- various forms of debilitating and painful arthritis,
- vascular disorders,
- post-traumatic joint injury or malformation,
- certain deformities, and
- salvaging a knee that has endured previous surgeries.
Class II Recall of all Persona Knee Components
An insignificant amount of time passed before the FDA regretted its decision and issued a recall on Zimmers’ replacement knees. Specifically, the NextGen and Persona knee replacement systems were the subjects of the recall notice from Zimmer. Zimmer held FDA approval for approximately eight months before Zimmer issued the recall notice.
The FDA issued a Class II recall for the Persona prosthetic and related parts. Zimmer intended to replace the parts all of the prosthetic knee because Zimmer received complaints of the tibial plate failing and causing a perforation of the tibia. Stress applied to the perforation caused the tibia to break. The FDA determined that the recall was necessary because of a manufacturing and design defect.
The recall involved knee systems that had not been implanted. Those were collected and returned to the manufacturer immediately. Instructions distributed to physicians and hospitals indicated that all devices that had been implanted in patients should be removed. Fortunately, only 92 of these units were circulated.
A Second Recall
Zimmer’s poor manufacturing and design techniques arose again in 2015. On March 12, 2015, the FDA issued another recall notice for Zimmer’s Persona Trabecular Tibia Plate. This device loosened after implantation and also caused what doctors described as “radiolucent lines.” A radiolucent line is a deformation that cannot be observed by an X-ray exam because radiation passes through a radiolucent line.
Zimmer released almost 12,000 of these defective units into circulation. Distribution of the faulty knee reached many states within the U.S. and several countries across the globe. Additionally, the U.S. Veterans’ Administration Medical Centers. The FDA did not determine a cause at the time they issued the recall but indicated that Zimmer had the reason under investigation. The recall warned that all of the units in circulation must be returned to the company.
Many knee replacement patients needed to have another knee replacement surgery to replace the defective knee components. Typically, a knee replacement can last around 15 years. Some patients who received Zimmer replacement knees lasted only two years before going under the knife again.This is called revision surgery.
As with the Persona knee replacement system, the FDA approved the second Persona system under its authority granted by Section 510(k). One must question whether the Section 510(k) process works given the troubles Zimmer experienced with its knee replacement devices.
In 2011, people injured by Zimmer’s defective products brought claims in court seeking damages. In response to the flood of litigation, a federal judge in the Northern District of Illinois consolidated these cases in a particular lawsuit called “Multidistrict Litigation (MDL).”The parties in the MDL selected three cases to go to trial to this point as “bellwether” trials. These cases selected for trial are representative of the most of the 1,700 cases pending at one time against Zimmer. This is not a class action lawsuit because each case is distinct from all others.
Zimmer has prevailed in these bellwether trials. However, the judge has allowed other cases togo to trial. The parties have settled many of the cases filed against Zimmer.In addition, many of the plaintiffs have asked the judge presiding over the litigation to be released from the MDL to return to their respective state courts where they might fare better.
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