A federal employee has filed a lawsuit against a major medical device company, alleging severe complications from a knee replacement system. Christy Stelly filed the complaint in the United States District Court for the Eastern District of Louisiana on September 17, 2024, naming DePuy Synthes Products, Inc., among other defendants.
According to the court documents, Stelly underwent a right total knee replacement surgery at Ochsner Medical Center on June 21, 2022. The surgery involved the implantation of the DePuy Attune Knee System Device. Despite initial assurances from DePuy that their product would provide better stability and longevity compared to previous models, Stelly experienced significant post-surgical pain and instability. By October 2023, her surgeon recommended revision surgery due to aseptic loosening of the knee replacement.
The complaint details how DePuy received FDA clearance for the Attune Device in December 2010 under Section 510(k) of the Federal Food, Drug and Cosmetic Act. This section allows faster approval for products deemed substantially equivalent to previously approved devices. However, starting in late 2013, reports began surfacing about high failure rates associated with the device's tibial base component. Despite these reports and subsequent design changes introduced in 2016 aimed at addressing these issues, DePuy continued to market and sell the original defective components.
Stelly's lawsuit accuses DePuy of several violations under Louisiana law, including design defect (LSA-RSS. 9:2800.56), failure to warn (LSA RS. 9:2800.57), breach of express warranty (LSA R:S. 9:2800.58), and manufacturing defect (R.S.2800.55). The plaintiff argues that alternative designs existed that could have prevented her injuries and that DePuy failed to provide adequate warnings about known risks associated with their product.
In addition to seeking compensatory damages for physical pain, disability, mental anguish, medical expenses, and future surgeries, Stelly is also demanding a jury trial for all claims brought forth in her complaint.
Representing Christy Stelly are attorneys Louis L. Gertler and Helen H. Babin from Gertler Law Firm LLP based in New Orleans.