If you or a loved one has suffered complications from an osseointegration implant, the personal injury attorneys at Levine & Slavit, PLLC, are here to help. You may be entitled to compensation. Osseointegration technology has revolutionized medical care for millions of patients, but when these devices fail due to defects in design or manufacturing, the consequences can be devastating. This guide explains what osseointegration is, the types of devices involved, common complications that may indicate a defective product, and your legal options.

What Is Osseointegration?

Osseointegration refers to the direct structural and functional connection between living bone and an artificial implant. The term comes from the Latin words “osseus” (bony) and “integrare” (to make whole). When an implant is osseointegrated, new bone grows directly onto the implant surface without any intervening soft tissue, creating a stable, permanent bond.

This technology was first discovered in the 1960s when researchers observed that titanium implants fused with bone tissue. Since then, osseointegration has become the foundation for numerous medical devices designed to improve patients’ quality of life, including dental implants, bone-anchored hearing aids, and prosthetic limbs for amputees.

Types of Osseointegration Medical Devices

Dental Implants

Dental implants are the most common application of osseointegration technology, with approximately five million implants placed annually in the United States alone. These titanium posts are surgically inserted into the jawbone to serve as artificial tooth roots, supporting crowns, bridges, or dentures. While dental implants have high success rates, defective implants can lead to serious complications including infection, bone loss, and implant failure.

Bone-Anchored Hearing Aids

Osseointegrated bone conduction prostheses are surgically implanted hearing devices that transmit sound vibrations directly through the skull bone to the inner ear. These devices are used for patients with certain types of hearing loss or those who cannot tolerate conventional hearing aids. When these implants fail to properly integrate or are defectively designed, patients may experience device failure, chronic infections, or extrusion of the implant.

Prosthetic Limb Implants

Osseointegrated prosthetic limbs represent a significant advancement for amputees who struggle with traditional socket prostheses. The OPRA (Osseointegrated Prostheses for the Rehabilitation of Amputees) Implant System, approved by the FDA in 2020, allows a prosthetic limb to be directly attached to the patient’s skeleton. The FDA classifies these as Class III devices, meaning they carry the highest risk and require the most stringent regulatory controls. While these devices can dramatically improve quality of life, they also carry significant risks including deep infections, bone fractures, and implant loosening.

Orthopedic Joint Replacements

Hip and knee replacement devices also rely on osseointegration to anchor the prosthetic joint to the patient’s bone. Defective designs, such as metal-on-metal hip implants, have resulted in thousands of lawsuits against manufacturers like DePuy, Stryker, and others. These defective devices have caused metal poisoning, tissue damage, premature failure, and the need for painful revision surgeries.

Warning Signs: Complications That May Indicate a Defective Device

Not all complications indicate a defective product, but certain symptoms warrant investigation. If you experience any of the following after receiving an osseointegration implant, you should consult both a medical professional and an attorney:

Peri-implantitis and Infection: This inflammatory condition affects the tissue surrounding dental and other implants. Symptoms include redness, swelling, bleeding, pus discharge, and progressive bone loss around the implant. Peri-implantitis is present in approximately 34% of dental implant patients and is a leading cause of implant failure. Deep infections in prosthetic limb implants carry a 10-year risk of approximately 20% and may require surgical intervention or implant removal.

Implant Loosening or Movement: A properly osseointegrated implant should be completely stable. If you notice movement, wobbling, or loosening of your implant, this may indicate failed osseointegration due to a design defect, manufacturing error, or improper surface treatment of the implant.

Implant Fracture or Breakage: While implants are designed to withstand normal use, defective materials or poor design can lead to fractures. This is particularly serious with prosthetic limb implants, where mechanical complications including abutment damage, screw loosening, and implant breakage have been documented.

Bone Loss and Resorption: Progressive bone loss around an implant can compromise stability and lead to implant failure. This can result from design flaws that create stress concentration or improper surface treatments that fail to promote healthy bone integration.

Nerve Damage: Numbness, tingling, or persistent pain following implant surgery may indicate nerve damage. While this can result from surgical technique, it may also be caused by implant designs that are too large or improperly shaped for the anatomical location.

Premature Failure: Osseointegration implants are designed for long-term use. Dental implants should last decades, and prosthetic limb implants are expected to provide years of reliable function. If your device fails significantly earlier than expected, this may indicate a defect. Some defective knee implants designed to last 12-20 years have failed within just one to two years.

Metal Poisoning or Adverse Tissue Reactions: Metal-on-metal joint implants have been associated with metallosis, a condition where metal particles are released into surrounding tissue, causing pain, swelling, tissue death (necrosis), and systemic effects from metal ions entering the bloodstream.

Your Legal Rights After an Osseointegration Device Injury

When a medical device causes injury due to defects, multiple parties may bear responsibility. Understanding who may be liable is the first step toward obtaining compensation for your injuries.

Manufacturer Liability

Medical device manufacturers have a duty to produce safe products, properly test their designs, and warn users of potential risks. When manufacturers fail in these duties, they may be held liable under product liability law. Claims against manufacturers typically fall into three categories: design defects (the product was inherently unsafe), manufacturing defects (errors occurred during production), and failure to warn (inadequate warnings about known risks). Major manufacturers including DePuy, Stryker, and others have faced substantial lawsuits and paid millions in settlements and verdicts for defective implants.

Medical Provider Liability

In some cases, the healthcare provider who performed the implant procedure may also bear responsibility. If a surgeon failed to properly evaluate whether you were a good candidate for the procedure, used improper surgical technique, failed to follow up appropriately, or knew or should have known about problems with the device, a medical malpractice claim may be appropriate in addition to or instead of a product liability claim.

Types of Compensation Available

Victims of defective osseointegration devices may be entitled to compensation for medical expenses (past and future surgeries, medications, and treatments), lost wages and reduced earning capacity, pain and suffering, emotional distress, and in cases of particularly egregious conduct, punitive damages designed to punish the manufacturer and deter similar behavior. At Levine & Slavit, PLLC, we understand how  physically and emotionally devastating it can be when a medical device that has improved your quality of life fails.

Important Considerations for Your Case

Statute of Limitations: There are strict deadlines for filing personal injury and product liability lawsuits. These time limits vary by state and by the type of claim. It is critical to consult with an attorney as soon as possible to ensure your rights are protected.

Preserve Evidence: If your implant has been removed, it is important that it be preserved in the condition it was in when it was explanted for analysis. The device itself is often key evidence in proving a manufacturing or design defect. Medical records, imaging studies, and documentation of your symptoms are also crucial. Destruction or alteration of the implant can potentially jeopardize your claim, even if it was accidental.

Document Everything: Keep detailed records of all medical appointments, symptoms, expenses, and how your injury has affected your daily life. This documentation will be valuable in establishing the full extent of your damages.

Contact Levine & Slavit, PLLC for a Free Consultation

If you or a loved one has experienced complications from an osseointegration device, the experienced attorneys at Levine & Slavit, PLLC, are ready to fight for you. Our team understands the complex medical and legal issues involved in defective medical device cases. We have the resources to thoroughly investigate your claim, work with leading medical experts, and pursue the maximum compensation you deserve.

At Levine & Slavit, PLLC,we handle osseointegration injury cases on a contingency fee basis, meaning you pay no attorney fees unless we recover compensation for you. Our commitment is to provide compassionate, aggressive representation for victims of defective medical devices.

Don’t wait to protect your rights. Contact Levine & Slavit, PLLC, today for a free, confidential case evaluation. Call us or fill out our online contact form to get started.