Many Exactech patients have received a concerning letter from their surgeon and have questions. Since so many devices were recalled, patients want to know if they got an Exactech knee, ankle, or hip replacement and, if so, how to find out if the recall affects them.
If you have undergone joint replacement surgery and experienced severe problems, a qualified Florida mass tort lawyer at Fasig | Brooks could review your legal options. If you continue to suffer pain or need revision surgery, you might be entitled to compensation for your medical expenses, pain and suffering, and other damages.
Overview of the Exactech Recalls
Exactech has issued mass recalls for many of its knee, hip, and ankle replacement devices. Lawsuits against the company claim that patients with certain replacement implants require follow-up procedures to repair the damage caused by the devices. Our law firm’s product liability lawyers are currently handling these cases.
In June of 2021, surgeons and hospitals were notified of issues with some of Exactech’s hip replacement devices, and in August 2021, many knee and ankle products were recalled. In February 2022, Exactech sent another urgent correction notice to ankle and knee surgeons.
The notice stated that the company had expanded its August 2021 recall to include other arthroplasty polyethylene inserts that came in inadequate bags that the company had used since 2004. While the bags are technically designed to resist oxidation, there is no ethylene vinyl alcohol layer to protect the device from deterioration.
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Complications Caused by the Defective Exactech Devices
Due to this decreased resistance, oxygen gets to the polyethylene (UHMWPE) insert. This increases oxidation compared to compliant inserts with an additional barrier layer in the packaging.
The increased oxygen exposure can lead to the deterioration of the UHMWPE, resulting in the following issues:
- Premature wear
- Production of debris
- Bone loss
- Bone cell disintegration
- New or worsening pain
- Loosening of the implant
- Fatigue
- The need for corrective surgery
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Ankle and Knee Replacement Devices Affected by the Recall
The Food and Drug Administration (FDA) has classified the Exactech recall as a Class II.
More than 100,000 inserts used in the U.S. since 2004 were distributed in non-conforming packages. Exactech admits this. The recall applies to all non-conforming Exactech knee and ankle UHMWPE inserts.
Doctors have been warned to stop implanting recalled replacement devices. Exactech has provided a list of affected models, descriptions, product codes, and serial numbers on its website. The recall includes implants from the following ankle and knee products:
- Optetrak
- Optetrak Logic
- Truliant Knee Replacement
- Vantage Ankle Implants
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Hip Replacement Device Recalls
In addition to these knee and ankle implant recalls, some Exactech hip replacement devices have also been recalled. In June 2021, the company issued an urgent communication to doctors, hospitals, and other healthcare professionals.
The letter announced that many Connexion GXL hip replacement patients experienced wear problems leading to proximal osteolysis. The hip implant recalls affected approximately 90,000 hip replacements done with Exactech Connexion GLX liners.
Exactech dd Not Notify Individuals About the Recall
Not all ankle, hip, and knee replacement recipients have heard about the recalls. This is because Exactech did not notify these individuals directly. Instead, they provided surgeons with a template letter asking them to notify anyone who could have been affected by the faulty devices.
If a joint replacement patient has moved since their surgery or their doctor has retired, they may not have heard that their replacements could cause them harm.
While you can use Exactech’s online tool to find out whether your replacement was recalled, we strongly advise getting legal representation from Fasig | Brooks Law Offices before filing a claim. The online tool will ask you for your joint replacement device’s serial number, which will be listed in your medical records.
Exactech Complications
The early deterioration of ankle, hip, or knee replacements can lead to medical problems, including:
- Synovitis
- Bone osteolysis
- Revision, using a replacement insert
Exactech urges surgeons to keep an index of and monitor replacement patients for the following:
- New or increasing pain
- Problems putting weight on one leg
- Knee or ankle instability
- Swelling
- Grinding noises
- Osteolysis
- Other associated failures
Getting an X-Ray to Find Out if Your Device Is Functioning Correctly
In light of the recalls, your surgeon might suspect that a joint replacement implant has caused a complication. In that case, Exactech advises the doctor to take X-rays and recommends against the prophylactic removal of the device if the patient has no problems.
If premature wear is discovered, Exactech recommends that doctors consider a revision operation, but only if it aligns with their better judgment. As with any invasive medical procedure, doctors and patients should discuss the benefits and risks.
Available Compensation in an Exactech Lawsuit
An Exactech joint replacement recall settlement could cover damages, including:
- Medical treatment, including surgery, after your replacement device fails
- Medical bills stemming from the defective device
- Pain and suffering
- Lost income (past, present, and future)
- Lost or decreased earning capacity
- Loss of enjoyment
- Punitive damages
When our law firm accepts your case, our attorneys for Exactech lawsuits will work tirelessly to get full compensation for your damages caused by a defective joint replacement device.
Contact an Exactech Lawsuit Lawyer
Exactech has retained a settlement adjusting company, Broadspire, to process claims for individuals who choose to go directly through Exactech. However, we strongly advise pursuing a claim in that way. Filing a recall claim without a lawyer could result in a settlement that is less than your case is worth.
Exactech states that it will only cover “out-of-pocket expenses.” The company will not automatically pay for a replacement procedure. To get them to pay for it, you’d have to get the surgery and hope they reimburse you. Instead of contacting Exactech or Broadspire, contact a Fasig | Brooks Exactech lawsuit attorney today to schedule a free consultation.
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