Exactech is a global medical device company headquartered in Gainsville, Florida. Since it was founded in 1985, Exactech has specialized in surgical implant systems for use in joint replacement surgeries.
In February 2022, Exactech issued a recall that included more than 140,000 Opetetrak, Optetrak Logic, and Truliant knee replacement systems; 130,000 hip replacement systems; and 1,500 ankle replacement systems. These devices used polyethylene parts that, according to Exactech, were packaged - pre-implantation - in allegedly defective vacuum bags.
The apparent defect in these bags could allow oxidation of the parts, which could severely degrade the product and increase the risk of device failure once implanted. This process was causing the polyethylene insert to significantly degrade after packaging and lose its ability to function properly in the knee replacement system.
Over time, the degraded polyethylene inserts caused excessive friction and wear. This leads to the premature failure of the Exactech knee replacement systems. Eventually, failure of the knee replacement system requires the patient to undergo corrective surgery. Patients who experienced failure of their Exactech knee replacement system due to this manufacturing defect experienced significant pain and lack of mobility in their knees.
As Exactech has stated in its recall notice and in court filings, the oxidation could cause “accelerated wear debris production and bone loss, and/or component fatigue cracking/fracture, all leading to corrective revision surgery.” This “corrective” revision surgery can be more complicated and painful than original implantation surgery.
Which Exactech Units are Being Recalled?
Exactech began recalling polyethylene liners for some of its knee and ankle implants in August 2021. In February 2022, the company expanded the recall to include “all knee and ankle arthroplasty polyethylene inserts packaged in non-conforming bags regardless of label or shelf life,” according to Exactech’s recall notification.
Exactech recalled all Optetrak, Truliant and Vantage brand knee and ankle replacement liners manufactured from 2004 to present. The company advised surgeons not to implant nonconforming products and to return conforming and nonconforming devices to Exactech.
Recalled Exactech knee and ankle replacements include:
- Optetrak All-Polyethylene CR Tibial Components
- Optetrak All-Polyethylene PS Tibial Components
- Optetrak CR Tibial Inserts
- Optetrak CR Slope Tibial Inserts
- Optetrak PS Tibial Inserts
- Optetrak Hi-Flex PS Tibial Inserts
- Optetrak Logic CR Tibial Inserts
- Optetrak Logic CR Slope Tibial Inserts
- Optetrak Logic CRC Tibial Inserts
- Optetrak Logic PS Tibial Inserts
- Optetrak Logic PSC Tibial Inserts
- Optetrak Logic CC Tibial Inserts
- Truliant CR Tibial Inserts
- Truliant CR Slope Tibial Inserts
- Truliant CRC Tibial Inserts
- Truliant PS Tibial Inserts
- Truliant PSC Tibial Inserts
- Vantage Fixed-Bearing Liner Component
If you have an Exactech implant and aren’t sure if it’s recalled, you can look up the serial number of your device on Exactech’s website.
Watch for Possible Symptoms
Symptoms associated with polyethylene wear are usually related to bone loss or excessive particle debris being released from the degraded liner. But some people may suffer bone loss, also called osteolysis, without symptoms.
Make sure you contact your doctor to see if you need to monitor your implant for potential future issues even if you don’t have symptoms now.
Symptoms to watch for include:
- Clicking in your knee, ankle, or hip
- Inability to bear weight
- Noises such as grinding coming from the implant
- Pain while walking
- Swelling in the joint
If you have any of these symptoms, contact your doctor right away. They can discuss treatment options, including potential revision surgery to replace the defective insert or the entire device.
What Should I Do If I Received a Potentially Defective Exactech Implant?
Anyone who’s received an Exactech knee, ankle, or hip replacement device since 2004 should first speak with a medical professional to determine if they need additional surgery to replace the defective device, especially if you’re experiencing pain or discomfort. Next, you should speak with an attorney about your legal options, as you could be eligible to file a lawsuit.
Patients can file a personal injury lawsuit seeking compensation for their pain and suffering, medical expenses including the cost of replacement surgery, lost past and future wages and punitive damages.
Exactech sent out a letter to doctors regarding the recall. The letter instructs surgeons to immediately stop using Exactech implants in all knee and ankle replacement surgeries. Doctors and hospitals are also instructed to return their existing inventory of recalled devices for replacement.
As for surgery patients who already have an Exactech knee replacement system implanted, the recall letter instructs them to consult with their doctors. Doctors are advised to maintain an index of all patients with Exactech implants and closely monitor them for signs of potential insert failure.
How Much Can I Recover from Exactech for My Defective Device?
The specific amount you’ll recover from your lawsuit will depend on the circumstances surrounding your case. Generally, the victims of Exactech’s negligence can expect to recover all the damages they sustained because of their defective knee replacement, including but not limited to:
- Lost wages
- Medical expenses
- Pain and suffering
- Emotional damage
- Diminished/loss of earning capacity
If you have any damages not listed above, be sure to mention them during your consultation. You might find you’re eligible to recover them as well, which is always better than paying out of pocket.
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