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          Risks with Exactech Joint Replacement Devices with Defective Packaging - FDA Safety CommunicationSafety Communications Risks with Exactech Joint Replacement Devices with Defective Packaging - FDA Safety Communication
  
  	
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Graphic with three circles with photos drawings of a knee, ankle and hip.  Each one contains a highlighted area showing where a replacement would go.
**Date Issued: March 23, 2023**

The U.S. Food and Drug Administration (FDA) is reminding patients and health care providers about Exactech joint replacement devices manufactured by Exactech between 2004 and August 2021, and recalled in 2021 and 2022. Many Exactech joint replacement devices (including knees, ankles, and hips) were packaged in defective packaging bags. The defective bags were missing one of the oxygen barrier layers that protect devices from oxidation, a chemical reaction with oxygen that can degrade plastics over time. Oxidation can lead to accelerated device wear/failure, and component cracking or fracture, all leading to corrective revision surgery. Some of the recalled devices are associated with increased risk of revision surgeries and bone loss related to excessive device wear/failure.

Recommendations for Patients

If your knee, ankle, or hip replacement device is functioning well and you have no pain or symptoms, the FDA does not recommend surgery to remove well-functioning Exactech joint replacement devices.
	Contact your health care provider if you have any Exactech joint replacement device implanted and you have any new or worsening pain or swelling, inability to bear weight, grinding or other noise, or weakness around your implanted device.
	If you have a knee or ankle replacement device, Exactech has an online database for knee and ankle devices that you can search to see if your implant is a part of their recall. You will need your device serial number.Recommendations for Health Care Providers

Do not implant any knee, ankle, and hip devices recalled by Exactech.
	Based on currently available information, the FDA does not recommend removal of well-functioning Exactech joint replacement devices from patients who do not have any new or worsening pain or symptoms.
	Monitor patients who have any implanted devices manufactured by Exactech between 2004 and August 2021 for potential device wear, failure, or bone loss. Consider performing X-rays to further evaluate a 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 clinical exam, 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.
	Remove all recalled devices from inventory and return to Exactech.
	Visit the Exactech Recall website for more information about the recalled knee, ankle, and hip devices and resources, including:
	Recall Serial Number Checker
		Exactech Letter for Knee and Ankle Surgeons, Hospital, Health Care Professionals
		Exactech Knee Patient Letter
		Exactech Ankle Patient Letter
		Exactech Recall Assistance Programs
		Exactech FAQs for Knee and Ankle Recall
		Exactech Letter for Hip Surgeons, Hospitals, Health Care Professionals (expanded)
		Exactech Hip Patient Letter
		Exactech Hip Recall (click the hip tab)Device Descriptions

Exactech joint replacement devices are used to replace painful, arthritic joints due to osteoarthritis, osteonecrosis, rheumatoid arthritis, and loss of normal structure and function in adults. These devices are also used to improve previously failed joint replacement devices with adequate bone and soft tissue are present. All Exactech joint replacement devices contain a plastic component which should be in packaging that contains multiple oxygen barrier layers as indicated in the package specification. The recalled devices were packaged in defective bags that were missing one of the oxygen barrier layers that protect devices from oxidation.

Defective bags may allow oxygen from the air to contact the plastic (polyethylene) component before it is implanted into a person’s body. If a large amount of oxygen contacts the plastic component before the device is implanted, it may lead to oxidation of the plastic component over time that can result in the risk of:

early and excessive device wear,
	component fracture,
	device failure,
	new or worsening pain,
	more bone loss,
	swelling in the affected area, or
	revision surgery as a result of these issues.Devices with Defective Packaging

**Knee and Ankle Replacement Devices**
	On February 7, 2022, Exactech expanded a voluntary recall on all Optetrak, Logic, and Truliant knee replacements and Vantage total ankle replacements packaged in defective bags regardless of a device’s label or shelf life. Exactech recalled the devices because around 80% of the knee and ankle replacement devices manufactured since 2004 were packaged in defective bags. Devices packaged in defective bags can lead to oxidation over time that results in the potential risks listed above. 
	On April 7, 2022, the company issued an updated Urgent Medical Device Correction notice with additional identified devices advising surgeons, hospitals, and health care providers to avoid implanting devices that were packaged in defective bags. Devices in defective bags were manufactured between 2004 and August 2021, and possibly implanted through February 7, 2022. The FDA classified these as a Class II recall on October 4, 2021.**Hip Replacement Devices**
	In June 2021, Exactech recalled some GXL Liners for Novation, Acumatch, and MCS hip replacement devices due to excessive and premature wear but the root cause was unknown. The FDA classified these as aClass II recall on July 22, 2021. 
	In August 2022, Exactech expanded the hip replacement device recall to include all hip devices with polyethylene components packaged in defective bags. The FDA classified these as a Class II recall on September 9, 2022.**The FDA is working with Exactech to assess whether any of its other joint implants that contain polyethylene components packaged in defective bags may result in increased oxidation and similar risks.**

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.

FDA Actions

The FDA will continue to work with Exactech to evaluate the risks of all joint devices 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. The FDA will keep patients and health care providers informed as significant information becomes available.

Questions?

If you need any further information or support concerning this issue, please visit the Exactech Recall Information website or call Exactech at 888-912-0403.
	For general questions, email the FDA’s Division of Industry and Consumer Education (DICE) at DICE@fda.hhs.gov or call 800-638-2041 or 301-796-7100.
	Find more information on FDA medical device recalls at What is a Medical Device Recall?

                                                                                  Content current as of:
      03/23/2023
              
              
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