Exactech, Inc., headquartered in Gainesville, Florida, issued a voluntary recall of its popular Exactech total knee replacement that was manufactured between the years of 2004 and 2022. The recall was issued on Feb. 7, 2022. The Exactech knee recall is centered around one component and insert of the knee replacement device.
On Mar. 23, 2023, the FDA issued a reannouncement of recalled Exactech medical device products. The majority of the recalled joint replacement devices (knees, ankles and hips) were defectively packaged. The bags were missing an oxygen barrier intended to protect against oxidation.
Why is the Exactech Knee Replacement Being Recalled?
According to the Exactech, Inc.
“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 the plastic to wear out earlier than expected or to become damaged after it is implanted into the patient’s body.”
“Exactech has found that the tibial plastic insert in the out of specification bag can wear out earlier than expected in some patients. Premature wear of the plastic insert of your knee replacement can lead to the need for additional surgery (also known as revision surgery). In those cases where the plastic has worn out earlier than expected or has been damaged, we will evaluate your knee replacement and decide whether additional treatment is needed. Determination of whether the plastic is worn is accomplished by examining your knee in the office and obtaining x-rays. After this evaluation is complete, we will decide if additional treatment, including revision surgery, is necessary.”
What symptoms can a patient experience with a recalled knee replacement product?
Patients with an implanted Exactech knee replacement can experience:
- New or worsening pain while walking
- Lack of stability
- Pain while bearing weight
- Swelling in or around the impacted joint
- Clicking or grinding noises and/or sensations from the joint
- Joint dislocation
- Pain in joint of affected knee
What models are affected by the recall?
Recalled Exactech knee and ankle replacements include the following models:
- 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
Consumers can also check their product’s serial number on Exactech’s recall serial number checker website.
Explanation of Exactech Knee Recall
As shown in the diagram below, a standard knee replacement has four parts:
- The femoral component (this is the metal piece that attaches to your thigh bone, also known as your “femur”)
- The tibial tray (this is the metal piece that fits into your shin bone, also known as your “tibia”)
- The patellar component (this is the piece of plastic that fits onto your kneecap, also known as the patella)
- The tibial polyethylene (plastic) insert (this is the plastic that fits between the femoral component and tibial component and acts as the new cushion or cartilage for your replaced knee joint)
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