Knee, Hip, and Ankle Recall
Upcoming Knee Replacement Lawsuits
Millions of patients have been implanted with Exactech Knee replacement systems since the devices were brought to market. However, design issues with the Exactech Optetrak, Truliant, and Logic knee replacement system and other knee implants have prompted the companies and the U.S. Food and Drug Administration (FDA) to issue warnings and recalls for the potentially dangerous product. Thousands of patients have experienced problems with this knee replacement, including accelerated knee wear, bone loss, and cracking or component fatigue that may require patients to undergo painful revision surgery to resolve implant complications.
In fact, in February 2022, an Exactech knee replacement recall was issued for more than 147,000 knee implants used since 2004. If you received a recalled Exactech Optetrak knee, settlement benefits may be available. Defective polyethylene inserts used with knee replacements may wear out and degrade prematurely, resulting in the need for an additional knee revision surgery.
The FDA has issued recalls after receiving numerous reports of knee implant failures. Those who have suffered from this device may have viable Exactech Optetrak Injury Lawsuits.
Exactech Knee Replacement Recall Information
On February 7, 2022, an Exactech knee replacement recall notice was sent to orthopedic surgeons throughout the United States, providing information about over 100,000 defective and dangerous knee inserts implanted in patients starting in 2004. The manufacturer also provided this recall letter that should be sent to all individuals who may be impacted by the defective implant. Although most consumers didn’t learn about this recall until 2022, the manufacturer first disclosed problems with the replacement inserts in August 2021. The recall has now been substantially expanded to include Exactech Optetrak knee replacements sold since 2004, Logic knee implants sold since 2009, and Truliant knee systems sold since 2017, regardless of any and all labels or shelf-life information.
Originally introduced in the United States in 1994, the manufacturers implant was on the market for about ten years before any significant changes were introduced. These changes were made to the manufacturing process for vacuum bags used for polyethylene inserts with these knee implants.
Most of this manufacturers knee implants sold since 2004 have been recalled, including:
- Exactech Optetrak CR Tibial Components
- Exactech Optetrak PS Tibial Components
- Exactech Optetrak CR Tibial Inserts
- Exactech Optetrak CR Slope Tibial Inserts
- Exactech Optetrak PS Tibial Inserts
- Exactech Optetrak HI-FLEX PS Tibial Inserts
- Exactech Optetrak Logic CR Tibial Inserts
- Exactech Optetrak Logic CR Slope Tibial Inserts
- Exactech Optetrak Logic CRC Tibial Inserts
- Exactech Optetrak Logic PS Tibial Inserts
- Exactech Optetrak Logic PSC Tibial Inserts
- Exactech Optetrak Logic CC Tibial Inserts
- Exactech Truliant CR Tibial Insert
- Exactech Truliant CR Slope Tibial Insert
- Exactech Truliant CRC Tibial Inserts
- Exactech Truliant PS Tibial Inserts
- Exactech Truliant PSC Tibial Inserts
What is the problem with Exactech Optetrak Knee Implants?
Individuals who received the now recalled knee implant may face an increased risk of experiencing problems with their Exactech Optetrak, Optetrak Logic or Truliant knee replacement. This may even result in the need for revision surgery after experiencing symptoms of additional knee problems.
A total knee replacement system includes a number of specific components (listed below), which all work together to provide an artificial knee replacement:
- Femoral Implant: metal piece that attaches to the thigh bone, known as the femur.
- Tibial Tray: metal piece that fits into the tibia or shin bone.
- Patellar Component: plastic piece that fits onto the knee cap or patella.
- Tibial Polyethylene Insert: plastic insert that fits between the femoral and tibial components to act as a cushion for the artificial knee joint.
The problem with these recalled knee implants is found in the polyethylene insert, which serves a critical function throughout the life of the knee replacement. The plastic knee insert is a “shock absorber” and replaces the function of cartilage in your knee joint. If the plastic insert fails, the knee replacement fails.
Officially known as an Exactech Ultra-High Molecular Weight Polyethylene (UHMWPE) knee insert, the knee replacement liners were found to be packaged in defective vacuum bags that were not sufficiently oxygen resistant. These polyethylene insert bags did not contain a second barrier layer containing ethylene vinyl alcohol (EVOH), which is intended to protect the knee insert from prematurely degenerating.
Oxygen may have reached the plastic inserts during storage or before it is implanted, resulting in oxidation that severely degrades the polyethylene liner. This increases the risk of several knee replacement problems much earlier than expected, including:
- Accelerated knee wear
- Debris production
- Bone loss
- Component cracking, fracture or fatigue
- Additional knee revision surgery
What are symptoms of replacement knee failure?
Any new or worsening symptoms with a knee replacement should be immediately reported to your surgeon, who will likely perform an examination and obtain knee x-rays to evaluate the device.
Symptoms of replacement knee failure caused by premature wear of the polyethylene insert may cause:
- New or worsening knee pain
- Knee swelling
- Pain while walking
- Inability to bear weight
- Knee instability
- Grinding, clicking or other noises from the knee implant
If it is found that you are experiencing problems or replacement knee failure, your surgeon may recommend knee revision surgery to remove or replace the components. An alternative to removal of the knee replacement may include surgery to exchange the polyethylene insert, one that was was packaged appropriately, which would have contained the necessary secondary oxygen barrier to prevent deterioration.
Even if you or a loved one have not experienced symptoms, knee recall settlements may still be available. Although the manufacturer is not currently recommending pre-emptive knee surgery to remove recalled knee implants that are not painful and continuing to function well, the recalled knee replacement will result in the need for additional medical monitoring and treatment.
Do You Qualify for a Knee Replacement Lawsuit Settlement?
If you or a loved one have undergone a total knee replacement since 2004 that may have involved an Exactech Optetrak, Exactech Optetrak Logic or Exactech Truliant knee implant, financial compensation and settlement benefits may be available. Additionally, It is not necessary that you know whether a recalled Extactech knee implant was used before contacting us to investigate further.
Call or text us today at 214 210 2100 or complete the form below to request a free case review. The information you provide about your knee replacement will be reviewed, and if it is determined that you may be eligible for a settlement we can discuss moving forward with a potential lawsuit.
As always, there are no fees or obligations associated with completing settlement evaluation with Forester Haynie.
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