Background: In recent years, the medical device sector has been positioned for consistent expansion, with worldwide yearly sales predicted to increase by more than 5% annually, reaching close to $800 billion by the year 2030 (van den Heuvel et al., 2018). In parallel to this growth, there is ongoing debate around the need for increased regulations and higher standards for medical device manufacturers, particularly as recalls have not decreased in frequency. The orthopaedic devices sector represents nearly 20% of the medical devices available on the global market and 16% average of these devices undergo recalls. Nonetheless, there exists a gap in the literature around investigations on orthopaedic knee implant recalls. (DeRuyter et al., 2023) This study aims to evaluate FDA recalls associated with orthopaedic knee implants, seeking to comprehend current orthopaedic knee implant recall’s trends and the reasons behind these recalls, and to determine the effectiveness of the current manufacturing quality standards and regulatory systems.

Methods: A quantitative monomethod was utilized, involving the distribution of an online survey to subject matter experts on recalls within the orthopaedic implant industries. The survey, administered via Microsoft Forms, comprised of 18 questions, encompassing both closed- and open-ended formats assessing the factors contributing to orthopaedic knee implant device recalls and the effectiveness of the current system and to provide suggestions and recommendations regarding Orthopaedic manufacturing standards, regulatory frameworks, and other relevant areas. Responses from a total of 71 participants were collected and data analysis undertaken to investigate the reasons behind recalls, contributors to these recalls, and the efficiency of the current manufacturing standard and regulatory system. Secondary research was also undertaken to detect prevailing trends in the recall of orthopaedic knee implant devices. Data was sourced from the FDA database, specifying the years 2019 to 2023, and filtered for details such as manufacturer, approval process, implant type, recall classification, recall dates, reasons determined by the manufacturer, quantity affected, and more. These data points were then analyzed utilizing histograms to visualize the frequency of recalls across each year.

Findings: FDA recall data has shown a significant increase in the number of recalls involving orthopaedic knee implants in recent years from different manufacturers. This increasing trend in recalls has raised concerns from both the medical community and among patients as they rely on these implants to regain mobility and improve their quality of life. These recalls, often attributed to issues such as manufacturing defects, material failures, or design flaws, underscore the challenges faced by manufacturers in ensuring the reliability and safety of these critical medical devices. Survey responses further highlight key factors contributing to orthopaedic recalls as perceived by participants. Manufacturing defects stand out as the primary concern, with a majority of respondents identifying them as the main contributors to orthopaedic recalls. This underscores the importance of addressing issues within the manufacturing process, including production errors, design flaws, and lapses in quality control, to uphold the reliability and safety of orthopaedic devices. Additionally, some respondents point to a lack of stringent FDA regulation as a significant factor contributing to orthopaedic recalls. This suggests apprehensions regarding the adequacy of regulatory oversight and enforcement, potentially resulting in compromises in product safety and quality standards. The response underscores the necessity for more robust regulatory measures to mitigate risks associated with orthopaedic devices.

Conclusions: The research findings emphasize the urgent need for a comprehensive and proactive approach to managing recalls of orthopedic knee implants, highlighting the deficiencies in the current system. Stakeholder feedback reveals diverse opinions on the necessary changes in the medical device landscape. Some stakeholders are satisfied with the current system when properly followed and advocate for no changes. However, others suggest improvements such as eliminating the predicated equivalent approval process, establishing a dedicated recall committee to review and refine the approval process as needed, and improving alignment between different international Quality Management System (QMS) standards, including ISO 13485 and FDA regulations. Additionally, stakeholders recommend integrating principles from ISO 14971 into QMS requirements to help manufacturers systematically identify, assess, and mitigate risks throughout the product lifecycle. Strengthening collaboration with small and medium-sized enterprises (SMEs) is also suggested, as suppliers often do not adhere to QMS certifications. Emphasis is placed on incorporating risk management ISO 14971 principles into QMS requirements, enhancing post-market surveillance, clinical evidence requirements, and regulatory measures, particularly in competitive and dynamic industries.