Medical device maker Exactech has issued a recall for thousands of total knee and ankle implants with plastic components and inserts that were improperly packaged in non-conforming vacuum bags. Exactech has discovered that the vacuum bags were missing a packaging layer designed to prevent oxygen from diffusing into the plastic component prior to it being implanted. As a result, the knee and ankle implants may fail earlier than expected and expose implant recipients to a risk of serious complications that may require revision surgery. To learn more about the Exactech knee and ankle device recall, or to find out if you are eligible to file a lawsuit against Exactech for a defective implant, contact Consumer Safety Watch today.
The Exactech recall affects all total knee replacement (TKR) and total ankle replacement (TAR) devices with polyethylene (plastic) components and inserts that were packaged in out-of-specification vacuum bags without a secondary barrier layer containing ethylene vinyl alcohol (EVOH). This includes more than 145,000 knee devices implanted between 2004 and 2022, and approximately 1,500 ankle devices implanted between 2017 and 2022. While the vacuum bags themselves are oxygen resistant, Exactech indicates in a Frequently Asked Questions document distributed to surgeons that the EVOH barrier layer “further augments oxygen resistance.” The missing barrier layer may cause the plastic components to wear out earlier than expected or become damaged after the device is implanted, which can increase the risk of mechanical failure, implant loosening, fracture, pain and swelling, bone loss, and the need for revision surgery.
Recipients of recalled Exactech total knee or ankle replacements who have experienced new or worsening pain, grinding in the replaced knee or ankle joint, inability to bear weight, instability, or swelling in the knee or ankle may need to have their defective implant removed or replaced. Affected individuals may be eligible to file an Exactech recall lawsuit against the manufacturer, in order to pursue compensation for their pain and suffering, medical bills, and other losses.
• 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
• TRULLIANT CR Tibial Inserts
• TRULLIANT CR Slope Tibial Inserts
• TRULLIANT CRC Tibial Inserts
• TRULLIANT PS Tibial Inserts
• TRULLIANT PSC Tibial Inserts
• VANTAGE Fixed-Bearing Liner Component
“Exactech Knee and Ankle Recall consists of more than 145,000 knee devices implanted between 2004 and 2022, and approximately 1,500 ankle devices implanted between 2017 and 2022.”
The issue that prompted the Exactech device recall involves the plastic insert that fits between the device components and acts as cartilage for the replaced knee or ankle joint. These plastic components are packaged in special vacuum bags meant to prevent the plastic insert from wearing prematurely prior to implantation. According to the Exactech recall, the out of specification bags missing this EVOH layer may allow oxygen to diffuse into the plastic insert before it is implanted, thus increasing the risk of device failure and other complications.
Exactech initially announced a recall of its knee and ankle arthroplasty polyethylene inserts in August 2021, after learning about a defect in the packaging. The original recall included devices labeled with an eight-year shelf life not packaged in EVOH bags. In a letter issued to surgeons in February 2022, the company expanded the medical device recall to include all knee and ankle implants packaged in non-conforming vacuum bags regardless of their label or shelf life. Unfortunately, between the recall in August 2021 and the update in February 2022, affected implants were shipped out by the company and implanted by surgeons across the country.
• Higher and earlier than expected revision rates
• Increased risk of polyethylene wear
• Possible risk of bone loss
• Mechanical failure
• Implant loosening
• Implant fracture
• Pain and swelling
• Instability of the knee or ankle joint
• Inability to bear weight on the joint
• Grinding in the replaced joint
Exactech’s total knee replacement (TKR) and total ankle replacement (TAR) replacement systems with polyethylene (plastic) components and inserts are used in knee and ankle replacement surgeries to provide relief to individuals with knee or ankle joints that have been damaged by arthritis or injury. Joint replacement surgery to replace a damaged knee or ankle joint with an artificial joint is a common procedure for those suffering from symptoms like pain, swelling, stiffness, and limited mobility that makes it difficult to perform daily activities. However, Exactech has confirmed that most of its TKR and TAR implants manufactured since 2004 were improperly packaged in faulty vacuum bags, which means the plastic insert may degrade prematurely, causing some implant recipients to experience significant pain requiring unnecessary corrective surgery. Exactech marketed its knee and ankle implants as safe and effective for joint replacement surgery and the company should be held responsible for the pain and other complications caused by the defect.
Class 2 Device Recall OPTETRAK Comprehensive Knee System
Exactech Recall Information | Surgeons and Patients
Look up the serial number of your product – If you have an Exactech knee or ankle polyethylene insert, check to see if the serial number of your implant is affected by a US product recall.
