According to documents filed with Kosciusko County Courts on Feb. 18, plaintiff Judy Day was surgically implanted with Zimmer’s Trilogy AB Acetbular System in her left hip by Michael Arata at Lutheran Musculoskeletal Center in Fort Waye on Aug. 21, 2008.
In February 2012, Day and her husband, Donald, were working as traveling missionaries in Spain. While shopping at a hardware store, Day took an awkward step (court documents stress she did not fall) and felt a crunching sensation in her left hip.
Day claims the defective hip replacement system caused her to suffer significant injuries, affected her ability to care for herself and permanently injured her. Additionally, the device malfunction forced her to make an unplanned trip back to the United States from Spain to undergo a costly and painful revision surgery to have the defective product removed.
Zimmer’s Trilogy AB system was approved for sale by the Food and Drug Administration in June 2006. To gain that approval, the company submitted to the FDA the results of a pre-clinical study of ceramic liners as party of its Summary of Safety and Effectiveness Data.
The study was based on 959 procedures using the TRANSCEND system, which differs from the Trilogy AB System. According to court documents, Zimmer acknowledges that it did not conduct pre-clinical trials on the Triology AB System, just compared it to results of tests conducted with the TRANSCEND system.
In June of 2012, Zimmer’s Puerto Rican manufacturing facility was found to be in violation of several FDA requirements, including failing to properly test devices. Two months later Zimmer withdrew its PMA application for the Trilogy AB System.
Multiple problems with the Trilogy AB System have been reported to the FDA, according to the court documents, including a ceramic shell insert fracture in December 2011 and a number of cracked liners in late 2011.
Also, in his article, “Fracture of a Ceramic Liner and Head in a Total Arthroplasty with a Sandwich Type Cup,” from “Case Reports in Orthopedics” on March 31, 2013, Diego Reategui revealed several problems with the device. Furthermore, Day’s surgeon, Michael Arata, reported problems with the device other patients.