Exactech Recall: Info for Exactech Knee Recall, Ankle Recall, and Hip Recall Patients

By Austin Kirk
Posted February 22, 2022

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Following reports of premature wear and early revision surgery, an Exactech recall was issued this month, impacting more than 147,000 knee implants and ankle implants placed in the bodies of Americans since 2004.

The Exactech knee recall and ankle recall impacts systems that contain a defectively packaged polyethylene plastic insert, which may deteriorate and cause the joint replacement to fail much earlier than expected.

This announcement came only a few months after a 2021 Exactech recall involving problems with about 90,000 Exactech hip replacements with Connexion GXL liners used since 2008, which also may wear out prematurely and fail.

These problems are causing patients throughout the United States to experience painful complications, often resulting in the need for revision surgery, continuing medical care and other damages caused by these defective and unreasonably dangerous implants.

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The lawyers at Saiontz & Kirk, P.A. are investigating Exactech knee recall lawsuits, Exactech hip recall lawsuits and Exactech ankle recall lawsuits for individuals who have experienced problems, including:

• Pain, swelling or difficulty bearing weight
• Loosening or instability in the joint
• Grinding, clicking or other noises from the implant
• Revision surgery or medical treatments resulting from the recalls

Although surgeons and hospitals received letters regarding the Exactech recalls between June 2021 and February 2022, the manufacturer has not made any effort to directly notify patients who received one of these implants. Instead, a template for an Exactech recall letter has been provided to surgeons, who have been asked to send the notification to all patients impacted.

Unfortunately, many individuals who received a recalled knee, ankle or hip replacement may never receive a letter or notification from Exactech or their surgeon.  However, they may still be eligible for financial compensation through an Exactech lawsuit

The Exactech recall lawyers at Saiontz & Kirk, P.A. are providing extensive information on this page for individuals who may have received a recalled Exactech knee, ankle or hip. Our law firm also provides free consultations and claim evaluations to review what legal options may be available, and help determine whether an Exactech recall settlement may be available

Why did I receive an Exactech recall letter?

On February 7, 2022, surgeons throughout the United States were provided a draft Exactech recall letter (PDF) that could be sent to patients. While some surgeons may have customized this recall notice, the letter sent by Exactech outlines the problems with certain knee and ankle implants packaged in “non-conforming” bags:

During a recent review of its knee implant manufacturing process, Exactech learned that one of the packaging layers for the plastic insert has been out of specification and may allow oxygen from the air to diffuse into the plastic insert prior to it being implanted in your knee. If a large amount of oxygen diffuses into the plastic insert while it’s being stored and before it is implanted, this can lead to a process called oxidation, which can cause plastic to wear out earlier than expected or to become damaged after it is implanted into the patient’s body.

Each of the recalled Exactech knee or ankle replacements contained a polyethylene plastic insert, which was packaged in a defective vacuum bag. These “out-of-specification” bags do not contain a secondary barrier layer of ethylene vinyl alcohol (EVOH), which provides critical oxygen resistance for the component.

The Exactech poly recall was issued since the defective bags may allow oxygen to diffuse the plastic insert, resulting in oxidation during storage or prior to the joint replacement surgery, placing patients at risk for:

• Degrading Exactech plastic insert
• Accelerated knee wear debris after implant
• Bone loss, loosening, lysis and pain after a knee replacement
• Component fatigue, cracking or fracture
• Premature knee revision surgery

Am I eligible for an Exactech recall lawsuit if I did not receive a letter?

Yes. Exactech lawsuit settlement benefits could be available for individuals who received a defective implant, even if they never receive an Exactech letter or recall notice from their surgeon.

Exactech recall letters are not being issued by the manufacturer or FDA. Rather, individual surgeons are being asked to notify patients who may be impacted by the Exactech recall. Therefore, many individuals will not receive a recall notice if they moved or lost contact with their doctor. In addition, if the surgeon retired, closed their practice or just fails to take proactive steps to notify former patients, an Exactech recall letter may never be sent.

Individuals also may never receive an Exactech recall notice if they have already had the recalled Exactech implant removed or undergone revision surgery after their joint failed.

Exactech lawsuit payouts can still be obtained, even if you never received an official recall letter!

What implants are impacted by the Exactech poly recall?

After initially recalling only a limited number of Exactech knee replacements in August 2021, the manufacturer has now widely expanded the recall to include all Exactech polyethylene inserts shipped with knee and ankle implants in non-conforming bags, regardless of the label or shelf-life of the product.

Knee Implants

Three different generations of knee replacements have used these recalled Exactech poly inserts at various points since 2004, including the Exactech Optetrak, Exactech Optetrak Logic and Exactect Truliant knee systems.

Ankle Replacements

The Exactech polyethylene recall has also impacted certain ankle replacements sold since 2016, including the Exactech Vantage ankle system.

Hip Implants

Finally, while not officially “recalled”, Exactech hip replacements implanted since 2008 may contain a defective polyethylene Connexion GXL acetabular liner, which has also been found to exhibit early signs of failure.

How do I find out if I have a recalled Exactech knee, ankle, or hip replacement?

Many individuals will not know the exact brand of Exactech knee or ankle implant used during their joint replacement surgery, or whether they received a defective plastic insert. Therefore, it may be necessary to obtain copies of medical records or contact your orthopedic surgeon to confirm the type of implant and serial number.

While the Exactech recall has not outlined the specific serial numbers for implants that were recalled, a webpage has been provided by the manufacturer where you can input the serial number for your implant and find out if it was recalled.

How serious is the Exactech knee recall?

Recalled Exactech implants pose a significant risk of catastrophic failure for your knee replacement, potentially resulting in unnecessary pain, early revision surgery and a diminished overall quality of life. Registry data has shown “statistically significant higher” Exactech Optetrak knee revision rates compared to other total knee replacement systems.

Reports of joint replacement problems tracked in Australia, New Zealand and the United Kingdom have found that the polyethylene plastic inserts used with Exactech knee implants are failing at an alarming rate.

• Australian Registry shows a greater than 10% knee revision rate with 14 to 20 years follow up (374 revisions among 3,684 Exactech Optetrak knee replacements with the polyethylene component)
• United Kingdom Registry shows significant increased cumulative revision rates for the Exactech Optetrak cruciate retaining femoral component at 3 year, 5 year, 10 year, 13 year and 15 year timepoints
• New Zealand Registry found a 9.5% rate of knee revisions with the Exactech Optetrak (63 revisions among 661 primary knee replacements)

The United States does not maintain a formal joint replacement registry. However, the manufacturer indicates that it estimates the Exactech Optetrak knee revision rate was 1.015/100 component years, compared to 0.48/100 component years for other knee replacements. This is a statistically significant two-fold increased risk!

However, the numbers are even worse when you only look at revisions that involve symptoms consistent with polyethylene wear (i.e. loosening, lysis and pain). There may actually be a three- to seven-fold failure rate in the most used Exactech Optetrak knee combinations.

Financial compensation and Exactech lawsuit settlements may be available for all individuals who received a recalled knee implant, even if you have not yet experienced problems. It is not necessary to know the type of implant was used during your surgery before requesting a free consultation and claim evaluation. Our knee replacement lawyers can help confirm the type of implant used and determine whether you may be eligible for an Exactech knee settlement.

Will I need knee revision surgery if I have a recalled Exactech implant?

Exactech has acknowledged that the recalled implants are prone to fail prematurely, which typically results in the need for knee revision surgery. However, pre-emptive removal of recalled knee implants is not being recommended by the manufacturer if the knee is not painful and functioning well.

Individuals who may be impacted by the Exactech recall should contact their surgeon and schedule an examination if they are experiencing any symptoms of knee replacement problems, including:

• New or worsening pain
• Inability to bear weight or difficulty walking
• Grinding, clicking or other noise from the knee implant
• Swelling
• Instability

Doctors will likely recommend an x-ray to evaluate the Exactech knee replacement and status of the recalled poly insert.

If knee revision surgery is not needed, surgeons are being encouraged to maintain an index of patients and monitor for any future risk of:

• Premature wear
• Osteolysis
• Knee failure

If a recalled Exactech knee implant has failed, doctors will likely consider revision surgery. However, as an alternative to knee revision surgery, some doctors may consider an isolated polyethylene insert exchange, as Exactech is providing new plastic knee and ankle inserts that they now indicate are properly packaged in conforming vacuum bags that will avoid future problems with premature wear and failure.

Should I file an Exactech recall claim with Broadspire?

As part of the recall announcement, Exactech indicates that it has already hired Broadspire, a settlement adjusting company, which will oversee a claims reimbursement process. The manufacturer only indicates that this will cover “recall-related out-of-pocket expenses”, and no information has been provided about what important rights individuals may give by filing an Exactech recall claim with Broadspire.

To present a claim, the manufacturer indicates that each individual impacted by the Exactech knee recall, Exactech ankle recall, or Exactech hip recall will be required to provide:

• Date of the joint replacement surgery where a recalled Exactech implant was used
• Name of the surgeon who performed the knee replacement, ankle replacement or hip replacement surgery
• Serial number for the implant, which is obtained from your medical records or surgeon

After contacting Broadspire about your Exactech recall claim, you will be assigned a claim number and receive instructions for how to submit expenses you have already incurred for reimbursement. However, our Exactech recall lawyers do NOT recommend that any potential clients contact Exactech or Broadspire directly before speaking with an attorney.

What will an Exactech recall settlement offer cover?

Any Exactech recall settlement should cover the full cost of all medical treatment and surgery required after a knee, ankle or hip replacement fails, as well as provide financial compensation for:

• Pain and suffering caused by the failed implant;
• Inconvenience and recovery time from additional surgery;
• Lost wages or loss of earning capacity;
• Past and future medical expenses that may be directly result from the recalled implant

The Exactech recall settlement program established so far only appears to cover reimbursement for “out-of-pocket” expenses incurred as a result of a revision surgery. This means that Exactech is not providing free examinations or joint replacement procedures, but rather requires individuals to incur these expenses on their own and then hope they get reimbursed.

Participating in the Exactech recall claim process may result in the loss of important rights, and information may be provided to Broadspire that may later be used to try to minimize the amount of any Exactech settlement you should be entitled to receive.

How do I file an Exactech Recall Lawsuit?

Through an individual Exactech recall lawsuit you will have the opportunity to obtain the maximum amount of financial compensation and damages available for all problems caused by a defective knee, ankle or hip replacement.

The Exactech recall lawyers at Saiontz & Kirk, P.A. provide free consultations and claim evaluations to review the legal options that are available, and there are never any fees or expenses unless you decide to move forward through our law firm and we win your case.

It is not necessary that you received an Exactech recall letter or confirm that you received a recalled knee, ankle or hip implant before contacting our law firm to start a free claim review.

FILE YOUR EXACTECH RECALL CLAIM