Medical device company Exactech, Inc., has issued recalls involving specific components used in its knee, hip, and ankle replacement systems due to an increased risk of premature failure.
As a result, some patients may require early revision surgery.
The polyethylene liners used in many of Exactech’s hip, knee, and ankle devices have been shown to fail more quickly due to liner wear, resulting in joint stiffness, pain, degeneration of the bone, and the need for early hip, knee, or ankle revision surgery.
Orthopedic surgeons recommend close surveillance of patients with these recalled devices. If you have a recalled Exactech hip, knee, or ankle implant, you may have a right to compensation.
Hip Recall
In June 2021, Exactech issued a Class II Medical Device Recall of its Exactech Connexion GXL acetabular polyethylene liners used in hip implants.
Although Exactech’s stated reason for the recall was that the “risk of edge-loading and premature prosthesis wear” was possible in a particular sub-group of patients with specific implant configurations, studies have shown a general link between catastrophic early polyethylene wear and the use of the Exactech Connexion GXL liner.
These studies found the average length between the initial implant and diagnosed hip implant failure to be five years or less.
Knee and Ankle Recall:
On February 7, 2022, Exactech recalled several of its knee and ankle systems again due to concerns that the polyethylene liners lead to accelerated excessive wear, bone loss, and device failure requiring revision surgery.
The recalled knee and ankle systems include:
- Optetrak (knee)
- Optetrak Logic (knee)
- Truliant (knee)
- Vantage (ankle)
As with the Exactech Connexion GXL hip liners, the tibial inserts/liners used in these knee and ankle implant systems exhibit early polyethylene wear, causing the devices to fail.
Click here to download the official Exactech recall letter for a complete description of the components involved.
FDA Alert Regarding Exactech Equinoxe Shoulder System
On January 16, 2024 the FDA issued an alert to patients and health care providers about possible health risks associated with the Equinoxe Shoulder System. These joint replacement devices were manufactured by Exactech between 2004 and August 2021 and were packaged in defective bags.
The defective bags used to package the Equinoxe Shoulder System devices were missing one of the oxygen barrier layers that protect the devices from oxidation, which can lead to faster device wear or failure, and device component cracking or fracture and require the need for revision surgery. If you have an Equinoxe Shoulder System implanted, and you are experiencing any new or worsening pain or swelling, inability to use your arm, grinding or other noise, or weakness around your implanted device, please contact your doctor and then call Meshbesher & Spence for an evaluation of your legal rights.
How Can an Exactech Recall Attorney Help
If you or a loved one received an Exactech hip, knee, or ankle replacement system and have experienced problems or had to undergo revision surgery, please get in touch with Meshbesher & Spence for a free consultation. You may have a right to compensation.
