Zimmer Biomet Holdings (ZBH) Risk Factor Changes

In addition, intellectual property laws differ in various jurisdictions in which we operate and are subject to change at any time, which could further restrict our ability to protect our intellectual property and prop…

Our business exposes us to potential product liability risks that are inherent in the design, manufacture and marketing of medical devices.

We are subject to laws and regulations that govern the collection, use, disclosure, transfer, storage, location, disposal, processing and protection of health-related, personal and other information.

We process personal and personal health data in our business, and certain of our products and services incorporate software or information technology that processes patient health data for treatment, maintenance and o…

If a regulator were to conclude that we are not in compliance with applicable laws or regulations, that any of our products are ineffective or pose an unreasonable health risk, that any of our products’ long-term stat…

Both before and after a product is commercially released, we have ongoing responsibilities under FDA regulations, the EU MDR, UK MDR and other national, regional, state and other requirements.

We operate in multiple countries and maintain a complex global supply chain and distribution network which exposes us to a variety of risks from U.S.

Tariffs, trade restrictions and other trade measures have adversely affected, and could continue to adversely affect, our business and financial results.

economic activities between or among these economies.

Furthermore, political tensions between the U.S., Canada, Mexico, China, Russia, Venezuela and certain other countries have escalated in recent years.

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We incurred substantial indebtedness in connection with previous mergers and acquisitions, and may incur substantial additional indebtedness in connection with future mergers and acquisitions.

Pricing pressure continues due to consolidation among healthcare providers, trends toward managed care, the shift toward governments becoming the primary payors of healthcare expenses, reductions in reimbursement leve…

Initiatives to limit the growth of general healthcare expenses and hospital costs are ongoing in the markets in which we do business, and we have experienced downward pressure on product pricing and other effects of h…

Cyber attacks are becoming more sophisticated, frequent and adaptive, and therefore, despite our efforts, we cannot assure that cybersecurity incidents or data breaches will not occur or that technology or information…

Our information systems, and those of third parties with whom we contract, require an ongoing commitment of significant resources to maintain, protect and enhance existing systems and develop new systems to keep pace…

We are dependent on sophisticated information technology for our products and infrastructure.

As a result of technology initiatives, changes in our system platforms and the ongoing integration of business acquisitions, we have been consolidating and integrating the ERP systems that we operate.

We and our third-party manufacturers have manufacturing sites all over the world.

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depending on their sites of care, such as hospitals, hospital systems, ambulatory surgical centers and doctors’ offices, and certain of our competitors have better capabilities to serve certain sites of care than we do.

Competition within our markets is primarily on the basis of technology, innovation, quality, reputation, customer service and pricing.

adverse regulatory action, depending on its magnitude, may restrict us from effectively manufacturing, marketing and selling our products and could have a material adverse effect on our business, financial condition a…

resulted in retaliatory tariffs by China and other countries.

Goodwill and intangible assets represent a significant portion of our assets.

Tax law changes in certain foreign jurisdictions in which we operate conforming to Pillar Two of the base erosion and profit shifting plan (“Pillar Two”) undertaken by the Organisation for Economic Co-operation and De…

Pricing pressure continues due to consolidation among healthcare providers, trends toward managed care, the shift toward governments becoming the primary payors of healthcare expenses, reductions in reimbursement leve…

party systems for maintenance and other purposes.

At the beginning of our third quarter of fiscal 2024, we began transitioning certain distribution and sales systems in the Americas to a new ERP system as part of a multi-year project.

demand in some instances.

intellectual property, we might be required to engage in costly and time-consuming litigation or other proceedings and we may not ultimately prevail.

privacy and data security laws that may apply to us, both because our operations are located in those countries and/or because we provide products and services to customers in those countries.

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but if the operating performance at one or more of our reporting units significantly declines, including if competing or alternative technologies or pharmacological treatments, emerge, if market conditions or future c…

Goodwill and intangible assets represent a significant portion of our assets.

The Organisation for Economic Co-operation and Development (OECD) has a framework to implement a global minimum corporate tax of 15% for companies with global revenue and profits above certain thresholds (referred to…

Companies across all industries are facing increasing scrutiny, and potentially negative actions, from investors, regulators, customers, employees and other stakeholders related to their corporate responsibility commi…

Our commitments, goals and disclosures related to corporate responsibility matters, and the perception of our activities in these areas, may adversely impact us.

Natural disasters present risks to our business and financial results which are difficult to predict and address.

Natural disasters, or legal, regulatory or market measures to address natural disasters, could materially adversely affect our business and financial results.

Further, our use of artificial intelligence and machine learning in our infrastructure and products exposes us to a variety of threats, risks and uncertainties, including with respect to changing laws and regulations…

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consideration of different regulatory requirements and approvals, preferences for different surgical techniques, reimbursement rates and other factors.

We are rationalizing our product portfolio to streamline our operations, enhance focus on strategic offerings, and improve cost efficiency.

Our product portfolio rationalization activities may not be successful or we may not fully realize the expected cost savings and/or operating efficiencies from our portfolio rationalization initiatives.

We are additionally making certain changes to our sales force and go-to-market models in certain other countries in an effort to optimize our commercial strategies and improve our performance on a consistent basis in…

We are converting substantial portions of our U.S.

We are transforming aspects of our sales and distribution network and go-to-market model in the U.S.