Zimmer Persona Knees
Pittsburgh residents and others in the surrounding Ohio Valley area who have undergone knee replacement surgery with a Zimmer Persona Knee and suffered from serious side effects may be entitled to compensation through a personal injury lawsuit.
Manufacturer of the knee device Zimmer Inc. recently implemented a nationwide recall of certain components of the Persona Knee, stating that the components could increase risk of loosening and lead to revision surgery.
The Pittsburgh lawyers at Chaffin Luhana are currently investigating cases in which the Zimmer Persona Knee did not perform as expected, leaving patients facing additional surgeries as well as months of pain, suffering, and unexpected medical costs. Families may be able to recover these and other expenses in court.
Zimmer Persona Knee Recall
In February 2015, Zimmer Inc. issued a nationwide recall for the Persona Trabecular Metal Tibial Plate—an important component of the Zimmer Persona Knee. The Tibial Plate forms the basis of the knee replacement device. The surgeon screws or pins the plate into the tibia, or shinbone, and then secures the rest of the device to the plate and the bone.
When Zimmer first released the Persona Knee in 2012, the company stated it was “ushering in a new era of personalization,” and that the Persona was the “most anatomically accurate knee implant,” “empowering surgeons to restore the unique identity of every knee.”
Zimmer designed the implant to have a number of options when it came to fitting patients, including a wide variety of component sizes, shapes, and constraint options “for optimized component fit and soft tissue balancing.” The goal was to help the implant better fit a variety of different sized knees in patients, and to offer options in both total and partial knee replacement surgery.
Unfortunately, it seems the company didn’t adequately test its components before releasing them onto the market.
The Problem with Zimmer Persona Knees
At issue with the Zimmer Persona Knee is the Tibial Plate and one of the tools the company designed to help surgeons when they were fitting the implant to patients’ knees. The plate was found to be associated with more reports of loosening than expected. In addition, the Tibial Articular Surface Provisional (TASP) Shim tool has also been found to have issues related to the ball bearings.
The FDA announced the Zimmer Trabecular Metal Tibial Plate recall on March 12, 2015, calling it a “Class II” recall, which means the device can cause “temporary” or “reversible” harm. Though a loose knee implant can be corrected through revision surgery, these additional surgeries often come with increased risk of side effects and often require longer recovery periods than initial knee replacement surgeries.
According to the FDA’s announcement, Zimmer implemented the recall of the plate “following an increase in complaints of radiolucent lines and loosening.” Radiolucent lines are lines that show up in an x-ray that indicate gaps between the device and the bone tissue. After implant surgery, a physician wants to see the plate fusing or “seating” well on the bone. Radiolucent lines show that there is space between the device and the bone, which increases risk of loosening and other implant problems.
Zimmer sent urgent recall notices to distributors, hospitals, and surgeons to alert them to the recall, and asked them to locate and quarantine all affected devices immediately. The recall is believed to affect nearly 12,000 components.
As for the TASP Shim, Zimmer designed it for use during Zimmer Persona Knee surgery. It allows the surgeon to identify how thick the knee implant needs to be, and to achieve range of motion for the joint itself. Reports indicated that the device was having issues with the ball bearings—doctors reported experiencing delays during surgery. The bearings were also sometimes left in the surgical wound. Zimmer issued a recall for this component in January 2014.
Zimmer Persona Knee Recall Injuries
Among the reports Zimmer received concerning problems with the tibial plate were the following:
• Persistent pain
• Difficulty walking or getting up from a seated position
• Knee instability; the feeling that one may fall
• Knee tightness
In addition to these symptoms, a Zimmer Persona Knee that is coming loose may also lead to the following complications:
• Bone fracture
• Loss of bone tissue; wearing away of bone
• Swelling and inflammation in the joint
• Complete implant failure
Patients who received a Zimmer Persona Knee and then experienced symptoms such as these need to talk to their doctors right away. If it is discovered that the device is not “seating” correctly, it may be necessary to correct it through revision surgery.
Zimmer Persona Knee Revision Surgery
During a Zimmer Persona Knee revision surgery, the physician will try to correct the problems associated with the implant. This may mean redoing the implant, or simply replacing certain components. According to the American Academy of Orthopaedic Surgeons (AAOS), revision surgery is different from primary total knee replacement: “It is a longer, more complex procedure that requires extensive planning, and specialized implants and tools to achieve a good result.”
Revision surgery differs in the following ways from the original replacement surgery:
• The surgery takes longer
• The bone may need to be rebuilt with metal pieces or a bone graft
• Damage to the bone may necessitate the need for specialized implant components that provide additional support
• It involves a greater risk of complications, including infection, poor wound healing, reduced range of motion, stiffness, bleeding, blood clots, and bone fracture during surgery
• It requires a longer recovery period
Patients who are required to go through revision surgery because of a defective implant may feel understandably cheated. A Zimmer Persona Knee lawsuit can help these patients to recover damages.
Fast-Track 510(k) Allowed Zimmer to Avoid Clinical Trials
The Zimmer Persona Knee was never subjected to clinical trials in humans. Though new devices are usually required to be tested before the FDA will approve them, this one gained FDA approval without tests.
Zimmer pursued approval through the FDA’s fast-track 510(k) program, which allows companies to apply for approval based on other similar devices. Zimmer was able to prove to the FDA’s satisfaction that the Zimmer Persona Knee was substantially similar to other knee replacement devices already being sold.
Though the 510(k) helps usher products to the market that may otherwise be caught up in years of red tape, it can also allow products like the Zimmer Persona Knee onto the market before they have been adequately tested and found to be safe.
In 2011, the Institute of Medicine (IOM) suggested the FDA get rid of the program, stating it did not do enough to protect the public. “The IOM finds that the current 510(k) process is flawed…” they stated, concluding that the “FDA’s finite resources would be better invested in” developing a new framework that “provides a reasonable assurance of safety and effectiveness throughout the device life cycle.”
The FDA did adjust the program in 2014, but the changes were not so significant as to have affected the approval of the Zimmer Persona Knee. Critics speculate that a more thorough approval and testing process may have detected the tibial plate problem before patients had to suffer through the consequences.
Zimmer Defending Thousands of Lawsuits
Zimmer has had problems with its joint replacement products in the past. In 2008, for example, they temporarily stopped sales on their Durom Cup hip implant because of reports of complications, including metal poisoning and tissue damage leading to premature loosening and failure of the implant.
A couple years later, the company recalled nearly 70,000 MIS Tibial components, again because of reports of premature loosening and implant failure. In 2014, the recalled about 40,000 NexGen knee implants because of defective screws.
Though Zimmer has always maintained that their medical devices are safe, they have been defending themselves against lawsuits for years because their products have not performed as advertised.
Pittsburgh Zimmer Persona Knee Lawyers Ready to Help
If you or a loved one received a Zimmer Persona Knee implant and then experienced symptoms of loosening or premature failure, you may be entitled to compensation. Patients shouldn’t have to shoulder the costs for revision surgery, recovery care, lost wages, and more on their own.
Chaffin Luhana warns that Zimmer may contact patients affected by the device recall to offer an early settlement in exchange for a waiving of rights. Be particularly cautious before signing any papers. A Zimmer Persona Knee lawyer can help advise you as to your best course of action.
Call today for a free and confidential case evaluation at 1-888-316-2311. Chaffin Luhana Pittsburgh attorneys represent individuals in West Virginia, Western Pennsylvania, and Eastern Ohio.