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From the FDA Access Data Website:
“These 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, a chemical reaction with oxygen that can degrade plastic components over time. Oxidation can lead to faster device wear or failure, and device component cracking or fracture. This could lead people with the device to need additional surgery to replace or correct the implanted Equinoxe Shoulder System.”
Understanding the Equinoxe Shoulder System
The Equinoxe Shoulder System is a widely used implant for shoulder replacement surgeries. It consists of various components, including glenoids, humeral liners, and augment options. These components are designed to provide stability, range of motion, and durability for patients undergoing shoulder arthroplasty.
The Glenoid Component
The glenoid component of the Equinoxe Shoulder System is available in different variations, including keeled and pegged options. The keeled glenoids offer cemented fixation and mate with specific head sizes and curvatures, such as alpha and beta curvatures. The pegged glenoids also provide cemented fixation and have similar mating options with head sizes and curvatures. It is important to note the compatibility of the glenoid component with different head sizes and curvatures to ensure proper alignment and function.
The Humeral Liners
The humeral liners play a crucial role in the Equinoxe Shoulder System, providing a smooth articulating surface for the humeral head. These liners are available in various sizes, including 36mm, 38mm, 42mm, 44mm, and 46mm options. Additionally, constrained humeral liners are also available for specific cases that require additional stability. It is important to select the appropriate size and type of humeral liner based on the patient’s specific needs and anatomical considerations.
Augment Options
The Equinoxe Shoulder System offers posterior augment options for cases that require additional support or reconstruction. These augment options are designed to address specific anatomical challenges and provide stability in complex cases. The posterior augment options are available for both left and right shoulders and are compatible with specific head sizes and curvatures.
The FDA Exactech Equinoxe Consumer Warning
The FDA has issued a consumer warning regarding the Exactech Equinoxe Shoulder System’s packaging. This warning highlights potential risks and concerns associated with the use of the system. It is crucial for healthcare professionals and patients to be aware of these risks and take appropriate measures to ensure patient safety.
“Some Equinoxe Shoulder Systems were packaged in defective bags that were missing one of the oxygen barrier layers that protect the devices from oxidation. Defective bags may allow oxygen from the air to contact the plastic (polyethylene) component of the Equinoxe Shoulder System before it is implanted into a person’s body.”
If a large amount of oxygen contacts the plastic component before the Equinoxe Shoulder System is implanted, it may lead to chemical change of the plastic component (oxidation). Oxidation of the plastic component over time can result in the risk of:
- Early and excessive device wear,
- Component fracture,
- Device failure,
- New or worsening pain,
- Bone loss,
- Swelling in the affected area, or
- Revision surgery as a result of these issues.
FDA Recommendations To Health Care Providers
As a result of the identified risks, the FDA has provided recommendations for healthcare professionals and patients using the Equinoxe Shoulder System.
- Do not implant any Equinoxe Shoulder Systems packaged in defective bags.
- Based on currently available information, the FDA does not recommend removal of well-functioning Equinoxe Shoulder Systems from patients who do not have any new or worsening pain or symptoms.
- Monitor patients who have an implanted Equinoxe Shoulder System manufactured by Exactech between 2004 and August 2021 for potential device wear, failure, or bone loss. Consider performing X-rays to further evaluate the patient and their implanted device if you suspect a failed device.
- Discuss revision surgery with patients who may have worsening pain or joint weakness that is potentially attributable to the device based on a clinical examination, on a case-by-case basis. As a part of shared decision-making, discuss the benefits and risks of all relevant treatment options with your patients.
Patients who have already undergone shoulder replacement surgery with the Equinoxe Shoulder System should be aware of the potential risks and complications. They should maintain regular follow-up appointments with their healthcare providers and report any symptoms or concerns promptly.
Source:
FDA Consumer Warning Exactech Equinoxe Shoulder System Defective Packaging Updated on January 17, 2024