Knee Replacement Systems Affected by the Exactech Recall
The recall for Exactech Knee replacements includes products under the OPTETRAK Comprehensive Knee System and TRULIANT Knee System and extends to some Exactech ankle replacement devices as well.
These systems include Ultra-High Molecular Weight Polyethylene (UHMWPE) inserts that fit between metal components. In recall documents from Exactech, the company states that out-of-specification packaging did not adequately protect the inserts from oxygen exposure. On February 7, 2022, the company sent an Urgent Medical Device Correction letter saying the oxygen exposure can cause the inserts to degrade over time, leading to early device failure.
The company has confirmed the packaging defect has been present since 2004, affecting about 147,732 devices that have been implanted in patients.
Problems Caused by the Recalled Exactech Devices
The recalled Exactech knee and ankle implants can result in serious problems for patients, including:
- Accelerated wear
- Debris production
- Bone loss
- Component fatigue requiring revision surgery to correct
- Component cracking or fracture requiring revision surgery to correct
Symptoms cited by Exactech patients include:
- Inability to bear weight
- Grinding noises from the device
- Clicking in the knee or ankle
What is Knee Revision Surgery?
Knee revision surgery is a corrective procedure to replace an old or defective implant in a patient. This is a very serious procedure that can take several hours to complete and is sometimes done in stages.
Risks patients face during Knee Revision Surgery include:
- Infection in the wound
- Poor wound healing
- Excessive bleeding
- Anesthesia complications
- Damage to blood vessels or nerves during surgery
- Bone fracture during surgery
- Bone loss
- Heart attack or lung complications during surgery
Full List of Recalled Exactech Knee and Ankle Replacement Products
- 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
- 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
What to Do If My Exactech Knee Replacement Is Recalled?
If you have received an Exactech knee or ankle replacement and now suffer from symptoms like pain and swelling or experience signs of device failure, you should contact your medical provider for evaluation.
If your Exactech device has been recalled, it is in your best interest to contact and device recall attorney for a FREE Case Consultation.
Thomas J. Henry Law can help you secure the financial compensation you need and deserve.