Mako Robotic Knee Replacement Complications: What Patients Should Know
The Mako robotic-arm assisted surgery system, manufactured by Stryker, has become one of the most widely used robotic platforms for knee and hip replacement procedures in the United States. Hospitals and orthopedic centers promote Mako-assisted surgery as more precise, less invasive, and better suited to achieving optimal implant placement than traditional manual techniques.
For many patients, the technology delivers on that promise. But robotic surgery is not risk-free, and when complications arise after a Mako procedure, patients often find themselves unsure whether their outcome was an unavoidable surgical risk or something that could have been prevented. Similar questions arise frequently with the da Vinci surgical system, the other dominant robotic platform in use today.
If you have experienced complications following a Mako robotic knee replacement, understanding what went wrong and whether anyone may be responsible is the first step toward protecting your health and your legal rights.
How the Mako System Works
The Mako system is not a fully autonomous robot. It is a surgeon-controlled robotic arm that assists with bone preparation during joint replacement surgery. Before the procedure, a CT scan of the patient’s knee is used to create a detailed 3D model of the joint. The surgeon uses this model to develop a personalized surgical plan, including the precise positioning and alignment of the implant.
During surgery, the surgeon guides the robotic arm to remove bone and prepare the joint surface according to the pre-operative plan. The system provides real-time feedback and is designed to help the surgeon stay within the planned boundaries, reducing the risk of removing too much or too little bone. The robotic arm can also provide haptic feedback, resisting the surgeon’s movements if the cutting instrument approaches the edge of the planned zone.
The Mako system is used for total knee replacement, partial knee replacement, and total hip replacement. Its claimed advantages include more accurate implant positioning, better soft tissue preservation, and potentially faster recovery compared to conventional surgery.
Common Mako Knee Replacement Complications
While the Mako system is designed to improve surgical precision, complications do occur. Some are common to all knee replacement procedures, while others are more specifically associated with robotic-assisted surgery.
Implant Misalignment
One of the primary selling points of the Mako system is its ability to achieve precise implant positioning. However, the technology does not guarantee perfect alignment in every case. If the pre-operative CT scan contains errors, if the surgical plan is flawed, or if the surgeon deviates from the plan during the procedure, the implant can be positioned incorrectly.
Misaligned implants can cause chronic pain, instability, uneven wear on the implant components, and reduced range of motion. In some cases, misalignment is severe enough to require revision surgery, a second major operation to remove and replace the implant.
Nerve Damage
Knee replacement surgery involves working near several important nerves, including the peroneal nerve that runs along the outside of the knee. Nerve damage during a Mako procedure can result in numbness, tingling, weakness, or foot drop, a condition where the patient has difficulty lifting the front of the foot. While some nerve injuries resolve over time, others are permanent and significantly affect mobility and quality of life.
Infection
Infection is a risk with any surgical procedure, but it is a particularly serious complication after joint replacement because it can compromise the implant. A deep infection around a knee implant may require additional surgeries, including removal of the implant, weeks of intravenous antibiotic therapy, and eventual reimplantation. Infection risk can be elevated if surgical instruments, including robotic components, are not properly sterilized, or if the procedure takes longer than expected and increases the exposure window.
Soft Tissue and Vascular Damage
The robotic arm operates with significant force, and if the system malfunctions or the surgeon loses control of the instrument, surrounding soft tissues, blood vessels, and ligaments can be damaged. Excessive bleeding, ligament tears, and damage to the joint capsule are complications that can occur during robotic-assisted knee surgery and may require additional treatment or revision procedures.
Need for Revision Surgery
Revision knee replacement is a more complex and challenging procedure than the initial surgery, with higher complication rates and often less favorable outcomes. When a Mako-assisted knee replacement fails prematurely due to implant misalignment, instability, or other complications, the patient faces the physical and financial burden of a second major surgery along with an extended recovery period.
For a broader overview of robotic surgery risks across different systems and procedures, visit our page on surgical robot injuries.
When Complications Become a Legal Issue
Not every complication after a Mako knee replacement is the result of negligence or a defective product. Knee replacement surgery carries inherent risks regardless of the technique used, and a poor outcome alone does not automatically mean someone is at fault. However, there are circumstances where complications may give rise to a valid legal claim.
Product Liability: Was the Mako System Defective?
A product liability claim focuses on whether the Mako system itself, or a component of it, was defective in a way that contributed to the patient’s injury. Potential product liability theories include:
Design defect. If the Mako system’s design contains a flaw that makes it unreasonably dangerous for its intended use, Stryker may be liable. This could include issues with the software that generates the surgical plan, the accuracy of the robotic arm’s movements, or the haptic feedback system that is supposed to prevent the surgeon from cutting outside the planned boundaries.
Manufacturing defect. If a specific Mako unit or component was flawed due to a manufacturing error, and that flaw contributed to a complication, the manufacturer may be responsible. This could include a malfunctioning robotic arm, defective cutting instruments, or a software error in a particular unit.
Failure to warn. If Stryker did not adequately warn surgeons about known limitations or risks associated with the Mako system, and a patient was harmed as a result, that failure may be grounds for a claim. Manufacturers have a duty to communicate known risks to the medical professionals who use their devices.
Medical Malpractice: Was the Surgeon Negligent?
A medical malpractice claim focuses on whether the surgeon or hospital fell below the accepted standard of care. In the context of Mako knee replacement, malpractice may involve:
Inadequate training on the robotic system. The Mako system has a learning curve, and surgeons who have not completed sufficient training and supervised cases may not be qualified to use it safely. If a surgeon’s inexperience with the system contributed to your complication, the surgeon and the hospital that credentialed them may be liable.
Errors in surgical planning. The surgeon is responsible for reviewing the pre-operative CT scan and developing an appropriate surgical plan. If the plan itself was flawed, for example, specifying incorrect implant sizing or placement, that is a surgeon decision rather than a technology failure.
Failure to respond to intraoperative problems. If the surgeon encountered unexpected difficulties during the procedure and failed to respond appropriately, such as continuing with the robotic approach when converting to a manual technique would have been safer, that judgment call may constitute malpractice.
Failure to obtain informed consent. Patients have the right to be informed about the material risks of their procedure, including the specific risks associated with robotic-assisted surgery. If your surgeon did not adequately disclose these risks before you agreed to the procedure, your consent may not have been legally valid.
In many cases, both product liability and medical malpractice theories may apply simultaneously. For example, if the surgeon was inadequately trained and the system also had a software error, both Stryker and the surgeon could share responsibility for the patient’s harm.
Steps to Take If You Have Experienced Complications
Seek follow-up medical care. If you are experiencing ongoing pain, instability, limited range of motion, numbness, or signs of infection after a Mako knee replacement, see a doctor promptly. Your health comes first, and timely medical documentation of your complications is also essential for any legal claim.
Request your complete medical records. You have the right to obtain your full surgical records, including the operative report, anesthesia records, imaging studies, and any notes about the robotic system’s performance during your procedure. These records are critical for evaluating what went wrong.
Be aware of time limits. Both medical malpractice and product liability claims are subject to statutes of limitations that vary by state. In many states, you have a limited window of one to three years from the date of the injury or from when you reasonably discovered the problem to file a lawsuit. Do not delay in seeking legal guidance.
What Should You Do Next?
If you believe your Mako robotic knee replacement complications were caused by a defective device, surgical negligence, or both, you have the right to explore your legal options. These cases require an attorney who understands the technical aspects of robotic-assisted surgery and can work with medical experts to determine whether your outcome was preventable.
Request a free case review to speak with an attorney who handles robotic surgery injury claims. There is no cost and no obligation. Understanding what happened and who may be responsible is the first step toward getting the answers and the compensation you deserve. For context on what robotic surgery injury cases have been worth, see our overview of da Vinci surgical robot settlement amounts.
This article is for informational purposes only and does not constitute legal advice. Injured By Robots LLC is not a law firm. Laws vary by state and may have changed since publication. Consult a licensed attorney in your state for advice about your specific situation.