Guest Editorial: Recalling a Recall

Like expert cabinetmakers, orthopaedic surgeons depend on the quality of the tools and devices we bring to our task. Unlike cabinetmakers, though, when our tools fall short of safety standards, they injure other people. As I’ve written elsewhere [2], the dismayingly high number of orthopaedic implants that have been cleared and then recalled by the US Food and Drug Administration (FDA) are causing serious, preventable harm. I know this firsthand because in 2021, Exactech, Inc. recalled its Optetrak TKA system due to nonconforming packaging for the polyethylene inserts it had been using since 2004 [1, 5]. This was the most common knee implant I had used in recent decades—I estimate that I had implanted about 1000 of them from 2004 to 2021. The recall was a catastrophe for many of my patients as well as a professional and personal crisis for me, which is why I feel compelled to share my story. The original total condylar and posterior-stabilized TKA implant designs were developed at my institution, the Hospital for Special Surgery (HSS), in the early 1970s by Peter Walker PhD, John Insall MD, and Chitranjan Ranawat MD [6]. In 1978, the total condylar design was modified with input from Albert Burstein PhD to create the posterior stabilized TKA that addressed the inadequate range of motion and instability found in the early design. Drs. Insall and Ranawat had a profound influence on my surgical training, and Dr. Burstein became an early mentor who inspired me to devote myself to an academic career as a clinician-scientist. Because of that personal exposure—along with the favorable clinical results that had been published with this device [10]—I adopted the Insall-Burstein II device as my TKA implant of choice. My early experience with it was outstanding, with almost no need for revision for mechanical issues. My patients were very pleased with their clinical results. In 1994, Exactech licensed the HSS design, incorporated some modifications, and released the Optetrak TKA system. Shortly after, I adopted it into my practice. For the next 15 years, Exactech appeared to be a supportive company, interested in gathering follow-up data to document the success of this new device. They launched a clinical database [4] to collect follow-up data longitudinally and provided research support to maintain it. Exactech also facilitated interactions among the users of its devices. I enjoyed working with other users of the Optetrak total knee system and was encouraged by reports of its long-term success [8]. I trusted Optetrak and Exactech and freely reported a conflict of interest that included royalties for design work and research support to my patients and colleagues. From 2010 to 2017, I began to encounter the occasional patient who would present 2 to 3 years following their TKA with unusual swelling and synovitis. Some patients underwent revision for pain, swelling, and instability, and unusual synovial expansion and wear of the tibial inserts were found. The problem was that these issues were so uncommon that neither I nor my colleagues recognized the emerging trend. Unfortunately, Exactech’s Optetrak database failed to recognize or report it, too. At HSS, all retrieved implants are sent to our biomechanics department for analysis. In 2017, the retrieval team reported to Exactech that they were seeing an unusually large number of deteriorated Exactech tibial inserts resulting from severe oxidative degradation of the polyethylene. Exactech responded by stating this had not been previously reported, and, to our surprise, suggested the problem was likely a technical issue with how our surgeons were performing the arthroplasties. Shortly thereafter, the arthroplasty service at HSS highly recommended against the routine use of the Exactech knee system at the institution. Exactech’s leaders continued to deny any knowledge of why this widespread problem was happening until one of their engineers discovered that the component packaging they had been using—possibly since 2004—was not impermeable to oxygen; it allowed oxidation of the polyethylene prior to implantation. By 2021, the FDA and Exactech had issued a full recall due to the poor performance of the polyethylene components [5]. The FDA notified all patients who had the Optetrak TKA implanted from 2004 to 2021 of the recall, recommending they contact their surgeons and the hospitals where the surgery was performed for clinical examination [3]. While HSS provided some clerical support along with a protocol for diagnosing and treating patients who had received the recalled Exactech devices [1], they made it very clear that it was my responsibility to reach out to the hundreds of patients whose prostheses were cited in the recall and provide the necessary surgical care. Over the next 18 months, my staff generated a daily list of 20 to 30 patients who I would personally call to see if they were experiencing symptoms of failure that required a follow-up office visit. Between 2021 and 2024, I performed 50 revisions of partial or all components, prompted by signs of swelling, pain, or frank radiographic loosening. My staff and I were devastated by the suffering our patients experienced. Unfortunately, several of these patients underwent multiple revisions and experienced serious complications following these procedures. Since I retired from surgery in 2024, my colleagues have had to perform additional revisions for some of my patients. One might argue that some failures of this kind cannot be avoided given the complexity of the production of orthopaedic implants. However, this recall exposed an elemental failure by Exactech to monitor and ensure the quality of their products. This was not a design flaw in the implant; it was the company’s failure to recognize a dangerous oversight that resulted from a change in their business practice. In this case, it was a packaging defect that was overlooked when Exactech employed a new vendor in 2004. Adding insult to injury, it later became known that several surgeons had reported their concerns, and several whistleblowers within Exactech had raised alarms well before 2017 [11]. The company responded by trying to manage this internally to avoid potential business repercussions of this failure [9]. Nonetheless, Exactech filed for bankruptcy in October 2024, and in September 2025, the company settled the False Claims Act lawsuits it was facing—which alleged it had billed Medicare for implants it knew were defective—and announced new ownership, as well as the formation of a trust to pay out any pending lawsuits [7]. Exactech’s handling of this failure exposed a violation of the important foundation of trust that is required in the relationship between physicians and industry. Although performing surgery requires a team of various partners—hospitals, device manufacturers, clinicians, to name a few—I felt I had to go it alone as I tried to support my patients through this crisis. Thankfully, my patients responded positively to my recommendations and typically accepted revision surgery when required. I remain extremely grateful for their patience and understanding. It is well understood that the modern orthopaedic surgeon benefits from decades of valuable technological achievements provided by implant manufacturers, and within our healthcare system, those companies must be profitable. Without healthy industrial partners, the orthopaedic profession cannot function—those profits help fund research and innovation that advance our field. Nevertheless, we should never accept the sacrifice of patient safety in order to protect those profits. This recall resulted in obvious harm to thousands of patients and shattered the trust of many others in our healthcare system. The pledge to do no harm is the primary commitment of our profession. How can we function if our industry partners do not accept this pledge, as well? Implant companies must be required to provide more comprehensive postmarket surveillance. Each revision must be considered a failure that prompts a formal root cause analysis, and when design or manufacturing defects are identified, they must be aggressively corrected. Over the past decade, surgeons and their hospitals have implemented many procedures, checklists, and reviews of unanticipated outcomes that have advanced the safety of our patients. It’s time for our implant companies to follow our example.