Adverse Events of Zimmer NexGen Knee Implants

Abstract

This report presents Zimmer Biomet NexGen knee implants, with consideration of data from the MAUDE database, by reviewing its clinical outcome and adverse events of the devices. Throughout this report, various configurations are taken into account for the NexGen implants: LPS or Legacy Posterior Stabilized, LPS Flex, CR or Cruciate Retaining, GSF or Gender Solutions Femoral, TM Tibial Component—each configuration exists with its own characteristics and problems. While TKA is generally one of the most important procedures for the treatment of severe knee arthritis, the NexGen series is one of the most important innovations in knee replacement technology. However, despite their innovative design, NexGen implants revealed some remarkable problems in clinical practice. Thus, according to the MAUDE database, during 2016-2024, there were 2,982 adverse events with NexGen knee implants reported, including typical complications related to implant loosening, mechanical failures, fractures, and infections. Not only do these adverse events have implications for patient outcomes, but several regulatory concerns also arise. The specific models, like LPS and LPS Flex, which offer benefits of advanced stability and high flexion, remain open to mechanical complications. The CR model, designed to conserve close-to-natural knee kinematics, is often unable to provide optimum ligament balance, hence leading to instability. Regulatory action by health authorities underlines the critical orthopaedic concerns posed by these implants, hence entailing continuous monitoring and improvement. The NJR and American Joint Registry datasets underline that, for example, NexGen implants are in high usage in England, Wales, and the United States, thereby indicating the global impact. This report seeks to emphasize the importance of collecting all data inclusively and targeted quality improvement initiatives to enhance patient safety and device performance.