KNEE REPLACEMENT LAWSUITS
Lawsuits allege the DePuy Synthes Attune Knee System is defective as adverse reports claim the tibial plate loosens causing extreme pain and suffering. Often the patient must undergo a revision surgery to replace all or portions of the original knee replacement. The FDA approved the Attune Knee System in 2013 with over 500,000 knee replacement surgeries performed. Plaintiffs allege many types of knee replacements are faulty, including:
- DePuy Synthes (Attune Knee system)
- Arthrex (iBalance Knee)
- B. Braun (Advanced Surface Ceramic Coated Knee)
- Exactech (Optetrack Knee)
- Stryker (Duration Unicompartmental Knee System)
- Zimmer Biomet (Nexgen) (Persona)
Complications associated with the knee replacements may include pain, difficulty walking, swelling, instability, infections, fractures, inflammation, loosening of implant. Often patients must undergo additional surgeries to remove or revise the implant. All surgeries carry risks, however, additional risks with revision surgery may include infection, bleeding, blood clots, bone fracture, nerves damage, and life-threatening issues of pulmonary embolism, heart attack or stroke.
In February 2016, Arthrex Inc. issued a Class II recall for the iBalance TKA Tibial Tray (Size 2) for knee replacements. Arthrex received reports of devices that had a smooth metal outer surface instead of a textured surface.
Attune Knee System
A study published in the Journal of Knee Surgery, reviewed some of the FDA reports to its Manufacturer and User Device Experience (MAUDE) database related to the Depuy Synthes Attune Knee System. A search of the MAUDE system results in a total of 232 reports related to the Attune TKA. Researchers reviewed clinical, radiographic and intraoperative findings for patients who received the Attune system and later required revision surgery, Three hospital databases were examined for such patients with tibial loosening at the implant-cement interface, producing a total of 15 cases.
“Patients presented with pain on weight bearing, effusion and decreased range of motion (ROM) within 2 years after surgery. Radiographic evaluation demonstrated loosening of the tibial components in 2 of 15 knees. This included cruciate retaining, posterior stabilized, fixed bearing and rotating platform bearing designs….Intraoperative findings demonstrated gross loosening of the tibial component at the implant-cement interface.”
Researchers indicated that 21 reports of tibial loosening at the implant-cement interface to MAUDE had been made, with “numerous other tibial failures” also reported without the mechanism for failure specified. “We believe that this complication is underreported due to failure of radiographs to assess loosening. In addition, MAUDE database reporting is not consistent and competing companies cannot provide data on the revised components. In patients who have negative workup for a painful joint, one must consider the diagnosis of debonding,” study authors wrote. A response published in the Journal of Knee Surgery, suggested that the issue needed further investigation and a possibly registry study to determine the depth of the issue.
Previous Knee Replacement Lawsuits and Settlements
Judge Rebecca Pallmeyer announced a global settlement in February 2018 of all cases in MDL 2272 In Re Zimmer NexGen Knee Implant Products Liability in the Northern District of Illinois. The multidistrict litigation began in 2011, with more than 1700 cases pending trial. Six cases were selected for bellwether trials, however, most were dismissed before trial. Following Judge Pallmeyer’s Lone Pine order, fewer than 300 cases remained in the MDL. Many plaintiffs requested their cases be remanded back to home district courts.
In 2008, Zimmer recalled the Durom Cup and Sulzer’s Natural Knee II Tibial Baseplate caused a small amount of oil to be left on the device which led to post-implantation problems leading to a recall of the devices.
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