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Risks with Exactech Equinoxe Shoulder System with Defective Packaging - FDA Safety Communication

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Illustration of a shoulder as part of the skeletal system.

Date Issued: January 16, 2024

The U.S. Food and Drug Administration (FDA) is alerting patients and health care providers about possible health risks associated with the Equinoxe Shoulder System joint replacement devices. 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.

Recommendations for Patients

  • If your Equinoxe Shoulder System is functioning well and you have no pain or symptoms, the FDA does not recommend surgery to remove a well-functioning device.
  • Contact your health care provider 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.

Recommendations for Health Care Providers

  • 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.

Device Description

Equinoxe Shoulder System implants are medical devices used in adults to replace painful, shoulder joints due to osteoarthritis, osteonecrosis, rheumatoid arthritis, and/or loss of normal structure and function. These devices are also used to improve previously failed shoulder joint replacement devices when adequate bone and soft tissue are present.

Defective Packaging

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.

Reporting Problems with Your Device

If you think you have a problem with your device, the FDA encourages you to report the problem through the MedWatch Voluntary Reporting Form or call 1-800-332-1088 for more information on how to mail or fax the form.

Health care personnel employed by facilities that are subject to the FDA's user facility reporting requirements should follow the reporting procedures established by their facilities.

Unique Device Identifier (UDI)

The unique device identifier (UDI) helps identify individual medical devices sold in the United States from manufacturing through distribution to patient use. The UDI allows for more accurate reporting, reviewing, and analyzing of adverse event reports so that devices can be identified, and problems potentially corrected more quickly.

You can find the affected Equinoxe shoulder devices, which have been initially identified as being packaged in the defective bags, by checking the UDI table below. The UDI is a unique numeric or alphanumeric code that generally includes a Device identifier (DI) that identifies the labeler and the specific version or model of a device, as well as a Production identifier (PI) that identifies additional information, which may include lot number, serial number, expiration date, and manufactured date.

FDA Actions

To date, Exactech has declined to initiate a voluntary recall for the Equinoxe Shoulder System implants packaged in the defective bags. The FDA will continue to work with Exactech to evaluate the risks of all joint devices that contain plastic components packaged in defective packaging and review information they provide regarding their joint replacement devices' safety and effectiveness.

The FDA is also working with international regulatory agencies to review additional, relevant data concerning the affected devices from registries and explore potential causes of the higher failure rates. The FDA will keep patients and health care providers informed as significant information becomes available.

The FDA issued a Safety Communication on March 23, 2023, about a similar issue with other Exactech joint replacement devices.

Questions?

If you have questions, email the FDA's Division of Industry and Consumer Education (DICE) at [email protected] or call 800-638-2041 or 301-796-7100.

 

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