Exactech Medical Device Injury Lawyer
Exactech hip, knee, and ankle replacement systems were implanted in tens of thousands of patients across the United States before a widespread recall exposed a critical packaging defect that caused the polyethylene components inside these devices to degrade prematurely. Patients who had these implants placed with the expectation of restored mobility instead faced accelerating bone and tissue damage, unexpected revision surgeries, and in many cases, permanent orthopedic consequences. An Exactech medical device injury lawyer at Leifer & Ramirez works with Florida patients and their families to pursue compensation from the manufacturers who knew, or should have known, that a packaging failure was causing their products to deteriorate inside patients’ bodies.
The recall at the center of these claims is one of the largest orthopedic device recalls in recent history. Exactech recalled hundreds of thousands of polyethylene tibial and acetabular inserts after discovering that non-conforming vacuum bags used during manufacturing allowed oxygen to enter the packaging and oxidize the plastic components. Oxidized polyethylene wears at a dramatically accelerated rate, causing implant failure, osteolysis (bone loss around the implant), joint instability, and pain that mimics the original condition the device was meant to treat. Many patients spent months or years seeking explanations for their worsening symptoms before the recall gave them answers.
Florida patients who received Exactech implants have particular reason to act promptly. The volume of revision surgeries tied to this recall has created a complex litigation environment where the documentation gathered early in the process, including operative reports, imaging, and medical records showing the progression of implant failure, plays a decisive role in how claims are evaluated and resolved. The attorneys at Leifer & Ramirez have handled defective medical device cases throughout South Florida and understand what it takes to build a claim that accounts for the full scope of a patient’s losses, not just the cost of a second surgery.
What Exactech Device Failure Actually Does to Patients
Understanding the specific harm caused by Exactech implant degradation matters when calculating damages, because the injuries are not simply a failed surgery requiring a redo. Oxidized polyethylene generates wear particles as the material breaks down. These particles trigger a localized inflammatory response in the surrounding tissue and bone, a process called osteolysis. Over time, the bone supporting the implant erodes, which can make revision surgery significantly more complicated and the outcomes less predictable than the original procedure. Surgeons performing revision operations on Exactech patients have reported substantial bone loss that requires additional grafting or the use of more complex implant systems.
The physical toll on patients is compounded by the timeline of these injuries. Because the degradation is internal and gradual, many patients did not connect their worsening pain, instability, or reduced range of motion to their implant until years after the original surgery. Some were treated for other causes of joint pain, prescribed additional medications, or underwent physical therapy that addressed symptoms without identifying the root cause. This delay in diagnosis affects both the medical outcome and the legal claim, which is why gathering a complete chronological record of the patient’s treatment history is one of the first priorities when these cases are evaluated.
Patients who received Exactech tibial inserts in knee replacements, acetabular inserts in hip replacements, or polyethylene components in ankle replacement systems may all be affected. The recall covered specific lot numbers across multiple product lines, so part of the early assessment in any claim involves confirming whether the specific components implanted in a patient were subject to recall and what the current condition of the device is on imaging.
Categories of Claims in Exactech Litigation
- Defective product liability: The core claim in Exactech cases rests on the manufacturer’s responsibility for placing a product with a known packaging defect into the market. Under Florida product liability law, manufacturers can be held responsible when a defect in the design, manufacture, or packaging of a product causes injury to the end user, regardless of whether the surgeon or hospital did anything wrong.
- Failure to warn: Exactech had an obligation to disclose known risks associated with their packaging and oxidation concerns to surgeons and patients in a timely manner. Evidence that the company was aware of packaging issues before issuing the recall supports a claim that adequate warnings were not provided when they should have been.
- Negligence in manufacturing and quality control: The use of non-conforming vacuum packaging represents a departure from accepted manufacturing standards. Patients whose implants failed as a result of that quality control lapse may pursue negligence claims tied directly to the manufacturing process.
- Revision surgery costs and future medical expenses: Damages in these cases typically include the full cost of revision surgery, hospitalization, anesthesia, post-operative rehabilitation, and any additional procedures required to address bone loss or implant complications resulting from the defective device.
- Lost income and reduced earning capacity: Patients who were unable to work during recovery from revision surgery, or who sustained permanent functional limitations affecting their ability to perform their job, may recover compensation for past and future lost earnings.
- Pain, suffering, and loss of quality of life: The experience of living with a degrading implant, undergoing a second major surgery, and managing ongoing orthopedic consequences carries real non-economic damages that Florida law permits injured patients to pursue.
- Wrongful death: In cases where complications from a defective Exactech implant contributed to a patient’s death, surviving family members may have a wrongful death claim under Florida law.
Building an Exactech Claim: What Florida Patients Need to Do Now
The steps a patient takes in the period immediately following a recall notification or a diagnosis of implant failure have a direct effect on the strength of the eventual claim. The most important immediate action is obtaining and preserving all medical records related to the original joint replacement surgery, including the operative report that should identify the specific implant components used, their lot numbers, and the manufacturer information. Hospitals and surgical centers in South Florida are required to maintain these records, but patients should request copies rather than assuming they will be available indefinitely.
Patients should also be evaluated by an orthopedic specialist who can document the current condition of the implant through updated imaging and clinical examination. The results of that evaluation, particularly any findings of osteolysis, instability, or abnormal wear, become part of the evidentiary record supporting the claim. If revision surgery has already been recommended, patients should ask their surgeon to retain any components removed during the procedure and to document findings in the operative report. Preserved explant material can be examined as evidence of the defect.
Defective medical device claims in Florida are governed by a statute of limitations that generally requires a claim to be filed within a set period from the time the patient knew or reasonably should have known of the injury and its connection to the product. Because many Exactech patients experienced a delayed connection between their symptoms and the recalled device, the specific clock in any individual case requires careful analysis. Waiting too long to consult an attorney risks forfeiting the ability to recover anything at all, which is why patients who received a recall notice or who are experiencing symptoms consistent with implant failure should seek legal guidance without delay.
Exactech litigation is proceeding in both federal multidistrict litigation and through individual state court filings. An Exactech attorney at Leifer & Ramirez can assess which path makes sense for a particular patient’s situation, explain what participation in MDL proceedings would mean as a practical matter, and make sure that Florida-specific procedural requirements are met throughout the process.
Why Leifer & Ramirez Handles Exactech and Defective Medical Device Cases
The attorneys at Leifer & Ramirez have spent over 25 years of combined experience representing injury victims throughout Florida, including clients harmed by defective products and dangerous medical devices. The firm has handled cases involving defective drugs, defective medical devices, knee and hip replacements, transvaginal mesh, and other medical products, giving the legal team direct experience with the medical and evidentiary complexities that separate strong device injury claims from weak ones.
The firm’s case results reflect what focused advocacy in serious injury and product liability matters can produce. Leifer & Ramirez has secured a $1,000,000 recovery in a slip and fall case where liability was initially disputed, an $837,500 recovery in a multi-vehicle accident involving complex injuries and substantial lost wages, and multiple other six-figure outcomes in cases where early assessments suggested limited recovery potential. For Exactech patients, what matters is that the attorneys handling these cases understand how to document the full scope of physical, financial, and personal harm caused by an implant failure, and how to press manufacturers for accountability when the evidence supports it.
The firm works on a contingency basis, meaning no fees or costs are charged unless a recovery is obtained for the client. Free consultations are available, including evening and weekend appointments, and the attorneys can come to the client when the client cannot easily travel. For patients recovering from revision surgery or managing ongoing orthopedic limitations, that accessibility matters.
Questions Florida Patients Ask About Exactech Claims
My hip replacement was done years ago. Am I still eligible to file a claim?
Possibly. Florida’s statute of limitations for product liability claims generally runs from the point when the patient knew or should have known that the product caused the injury, not necessarily from the original surgery date. Because Exactech’s recall was issued years after many devices were implanted, and because symptoms often developed gradually, the limitations analysis in these cases is fact-specific. A consultation with an attorney is the only way to determine whether your claim is still timely.
The recall notice said my device is affected but I have no symptoms. Should I still contact a lawyer?
Yes. The absence of current symptoms does not mean no damage has occurred. Osteolysis and implant degradation can progress without producing obvious pain in the early stages. If imaging has not been done since the recall was announced, patients with affected devices should consider requesting updated imaging from their orthopedic provider. Early documentation of any developing issues is important for both medical and legal reasons.
My surgeon says my implant looks fine on imaging. Can I still have a claim?
Current imaging showing no obvious failure does not necessarily eliminate a claim, particularly if the device remains in your body and is subject to the recall. The ongoing risk of accelerated wear from an oxidized component, along with monitoring costs and anxiety associated with a defective implant that has not yet been revised, may support some form of legal recovery. This is an area where consulting an attorney is worthwhile even if revision surgery has not yet been recommended.
Who is actually the defendant in an Exactech case, the manufacturer or the hospital where I had surgery?
The primary defendants in Exactech product liability claims are the device manufacturer and related corporate entities responsible for designing, manufacturing, and distributing the recalled components. In most cases, surgeons and hospitals are not directly implicated in the packaging defect itself, though there may be circumstances where additional parties are involved depending on the specific facts of a case. The investigation conducted at the outset of representation helps identify all potentially responsible parties.
I had a knee replacement, not a hip. Does this recall apply to me?
Yes. The Exactech recall covered polyethylene components used in multiple product lines, including tibial inserts used in knee replacement systems and acetabular inserts in hip replacement systems, as well as components in ankle replacement products. Whether your specific device falls within the recall depends on the lot number and product line, which can be confirmed by obtaining your operative report and cross-referencing it with the recall information.
What if I already had revision surgery? Can I still pursue a claim?
Having already undergone revision surgery does not bar a claim. In fact, revision surgery creates concrete, documented damages that can be central to the claim: the cost of the procedure, recovery time, lost wages, additional rehabilitation, and any ongoing complications. If explant material was retained from the revision, that may serve as additional evidence. Patients who have already had revisions should act promptly to gather their records before memories fade and documentation becomes harder to obtain.
Is the Exactech litigation handled as a class action or individual claims?
Exactech cases have been consolidated in federal multidistrict litigation, which groups cases for coordinated pretrial proceedings without eliminating each plaintiff’s individual claim. This is different from a class action, where a single recovery is shared among all class members. In MDL proceedings, each patient’s damages and circumstances remain individualized. The question of whether to file as part of the MDL or through state court is a strategic decision that depends on the specific facts of the case.
Will my health insurance cover revision surgery while my legal claim is pending?
Many patients with health insurance or Medicare can use those benefits to cover the cost of revision surgery while the legal claim is pending. However, health insurers and Medicare may assert a right to reimbursement, called a subrogation or lien, against any eventual legal recovery. Properly addressing these liens is an important part of resolving a device injury claim, and an attorney handling your case should manage that process as part of the representation.
How long does it typically take to resolve an Exactech claim?
Product liability claims against medical device manufacturers, particularly those involving MDL proceedings, generally take longer to resolve than a straightforward personal injury case. The timeline depends on many factors, including where the case is filed, the complexity of the individual patient’s medical history, and how the litigation progresses overall. Some claims resolve through settlement, others require more extensive litigation. An attorney can give a more specific estimate after reviewing the facts of your situation.
What documentation should I be gathering right now if I think I have an Exactech claim?
Priority documents include the operative report from your original joint replacement surgery (which should contain the implant lot number), all imaging studies taken before and after surgery, records from any follow-up appointments where you reported pain or instability, records from any treating physicians who evaluated your joint complaints, and any correspondence from Exactech, your hospital, or your surgeon related to the recall. If you have already had revision surgery, gather those operative records as well, and ask whether any removed components were retained.
Leifer & Ramirez Serves Exactech Injury Clients Across South Florida and the Treasure Coast
From our offices in Boca Raton, Fort Lauderdale, West Palm Beach, and Port St. Lucie, the firm represents Exactech injury clients throughout South Florida and beyond. Patients in the Boca Raton area, including those in Delray Beach, Boynton Beach, Highland Beach, and the communities of western Boca Raton, can reach the firm directly from Palm Beach County. We also serve clients throughout Broward County, including Fort Lauderdale, Pompano Beach, Deerfield Beach, Coconut Creek, Coral Springs, Tamarac, Plantation, Davie, Hollywood, and Hallandale Beach. Our West Palm Beach office serves clients in Lake Worth, Greenacres, Wellington, Royal Palm Beach, Palm Beach Gardens, Riviera Beach, Jupiter, and Tequesta. Through our Port St. Lucie location, we represent clients in Stuart, Hobe Sound, Jensen Beach, Fort Pierce, Okeechobee, and the broader Treasure Coast region. The firm also handles cases for clients in Miami-Dade County and across the state of Florida where serious medical device injuries are involved. Evening and weekend consultations are available, and the attorneys can travel to meet clients who are recovering from surgery or facing mobility limitations.
Contact an Exactech Medical Device Attorney at Leifer & Ramirez
A recalled implant that was supposed to restore function to a damaged joint and instead accelerated the breakdown of surrounding bone and tissue represents a serious breach of the responsibility medical device manufacturers owe to patients. An Exactech medical device attorney at Leifer & Ramirez can review your records, assess whether your device falls within the recall, and explain what a claim might realistically involve for your specific situation. The firm handles these cases on a contingency basis, with no fees or costs unless a recovery is obtained. Contact Leifer & Ramirez for a free, confidential consultation to discuss what your options look like and what steps to take next.
