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          Risks with Exactech Equinoxe Shoulder System with Defective Packaging - FDA Safety CommunicationSafety Communications 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.

How do I recognize a UDI on a label?
	AccessGUDID database - Identify Your Medical Device
	Benefits of a UDI SystemYou 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.

UDI Table
	Version or Model
			Device Description
			Device Identifier314-01-02
			GLENOID,KEELED, CEMENTED,Mates with 38, 41, 44 head, alpha curvature, Small
			10885862084408314-01-03
			GLENOID,KEELED, CEMENTED,Mates with 38, 41, 44 head, alpha curvature, Medium
			10885862084415314-01-04
			GLENOID,KEELED, CEMENTED,Mates with 38, 41, 44 head, alpha curvature, Large
			10885862084422314-01-12
			GLENOID,KEELED, CEMENTED,Mates with 47, 50, 53 head, beta curvature, Small
			10885862084439314-01-13
			GLENOID,KEELED, CEMENTED,Mates with 47, 50, 53 head, beta curvature, Medium
			10885862084446314-01-14
			GLENOID,KEELED, CEMENTED,Mates with 47, 50, 53 head, beta curvature, Large
			10885862084453314-01-15
			GLENOID,KEELED, CEMENTED,Mates with 47, 50, 53 head, beta curvature, Extra Large
			10885862084460314-02-02
			GLENOID,PEGGED, CEMENTED,Mates with 38, 41, 44 head, alpha curvature, Small
			10885862084477314-02-03
			GLENOID,PEGGED, CEMENTED,Mates with 38, 41, 44 head, alpha curvature, Medium
			10885862084484314-02-04
			GLENOID,PEGGED, CEMENTED,Mates with 38, 41, 44 head, alpha curvature, Large
			10885862084491314-02-12
			GLENOID,PEGGED, CEMENTED,Mates with 47, 50, 53 head, beta curvature, Small
			10885862084507314-02-13
			GLENOID,PEGGED, CEMENTED,Mates with 47, 50, 53 head, beta curvature, Medium
			10885862084514314-02-14
			GLENOID,PEGGED, CEMENTED,Mates with 47, 50, 53 head, beta curvature, Large
			10885862084521314-02-15
			GLENOID,PEGGED, CEMENTED,Mates with 47, 50, 53 head, beta curvature, Extra Large
			10885862084538314-02-22
			GLENOID, POSTERIOR AUGMENT,PEGGED, CEMENTED,Mates with 38, 41, 44, 47 head, Small, 8°,LEFT
			10885862175052314-02-23
			GLENOID, POSTERIOR AUGMENT,PEGGED, CEMENTED,Mates with 41, 44, 47, 50 head, Medium, 8°,LEFT
			10885862175069314-02-24
			GLENOID, POSTERIOR AUGMENT,PEGGED, CEMENTED,Mates with 44, 47, 50, 53 head, Large, 8°,LEFT
			10885862175076314-02-25
			GLENOID, POSTERIOR AUGMENT,PEGGED, CEMENTED,Mates with 44, 47, 50, 53 head, Extra Large, 8°,LEFT
			10885862175083314-02-32
			GLENOID, POSTERIOR AUGMENT,PEGGED, CEMENTED,Mates with 38, 41, 44, 47 head, Small, 8°,RIGHT
			10885862175090314-02-33
			GLENOID, POSTERIOR AUGMENT,PEGGED, CEMENTED,Mates with 41, 44, 47, 50 head, Medium, 8°,RIGHT
			10885862175106314-02-34
			GLENOID, POSTERIOR AUGMENT,PEGGED, CEMENTED,Mates with 44, 47, 50, 53 head, Large, 8°,RIGHT
			10885862175113314-02-35
			GLENOID, POSTERIOR AUGMENT,PEGGED, CEMENTED,Mates with 44, 47, 50, 53 head, Extra Large, 8°,RIGHT
			10885862175120314-04-22
			GLENOID,POSTERIOR AUGMENT, PEGGED,Mates with 38, 41, 44, 47 head, FOR CEMENTED USE ONLY, Small, 12°,LEFT
			10885862199553314-04-23
			GLENOID,POSTERIOR AUGMENT, PEGGED,Mates with 41, 44, 47, 50 head, FOR CEMENTED USE ONLY, Medium, 12°,LEFT
			10885862199560314-04-24
			GLENOID,POSTERIOR AUGMENT, PEGGED,Mates with 44, 47, 50, 53 head, FOR CEMENTED USE ONLY, Large, 12°,LEFT
			10885862199577314-04-25
			GLENOID,POSTERIOR AUGMENT, PEGGED,Mates with 44, 47, 50, 53 head, FOR CEMENTED USE ONLY, Extra Large, 12°,LEFT
			10885862199584314-04-32
			GLENOID,POSTERIOR AUGMENT, PEGGED,Mates with 38, 41, 44, 47 head, FOR CEMENTED USE ONLY, Small, 12°,RIGHT
			10885862198495314-04-33
			GLENOID,POSTERIOR AUGMENT, PEGGED,Mates with 41, 44, 47, 50 head, FOR CEMENTED USE ONLY, Medium, 12°,RIGHT
			10885862198501314-04-34
			GLENOID,POSTERIOR AUGMENT, PEGGED,Mates with 44, 47, 50, 53 head, FOR CEMENTED USE ONLY, Large, 12°,RIGHT
			10885862198518314-04-35
			GLENOID,POSTERIOR AUGMENT, PEGGED,Mates with 44, 47, 50, 53 head, FOR CEMENTED USE ONLY, Extra Large, 12°,RIGHT
			10885862198525314-06-22
			GLENOID,POSTERIOR AUGMENT, PEGGED,Mates with 38, 41, 44, 47 head, FOR CEMENTED USE ONLY, Small, 16°,LEFT
			10885862228307314-06-23
			GLENOID,POSTERIOR AUGMENT, PEGGED,Mates with 41, 44, 47, 50 head, FOR CEMENTED USE ONLY, Medium, 16°,LEFT
			10885862228314314-06-24
			GLENOID,POSTERIOR AUGMENT, PEGGED,Mates with 44, 47, 50, 53 head, FOR CEMENTED USE ONLY, Large, 16°,LEFT
			10885862228321314-06-25
			GLENOID,POSTERIOR AUGMENT, PEGGED,Mates with 44, 47, 50, 53 head, FOR CEMENTED USE ONLY, Extra Large, 16°,LEFT
			10885862228338314-06-32
			GLENOID,POSTERIOR AUGMENT, PEGGED,Mates with 38, 41, 44, 47 head, FOR CEMENTED USE ONLY, Small, 16°,RIGHT
			10885862228345314-06-33
			GLENOID,POSTERIOR AUGMENT, PEGGED,Mates with 41, 44, 47, 50 head, FOR CEMENTED USE ONLY, Medium, 16°,RIGHT
			10885862228352314-06-34
			GLENOID,POSTERIOR AUGMENT, PEGGED,Mates with 44, 47, 50, 53 head, FOR CEMENTED USE ONLY, Large, 16°,RIGHT
			10885862228369314-06-35
			GLENOID,POSTERIOR AUGMENT, PEGGED,Mates with 44, 47, 50, 53 head, FOR CEMENTED USE ONLY, Extra Large, 16°,RIGHT
			10885862228376314-13-02
			CAGE GLENOID, CEMENTED,Mates with 38, 41, 44 head, alpha curvature,Small
			10885862172679314-13-03
			CAGE GLENOID, CEMENTED,Mates with 38, 41, 44 head, alpha curvature,Medium
			10885862172686314-13-04
			CAGE GLENOID, CEMENTED,Mates with 38, 41, 44 head, alpha curvature,Large
			10885862172709314-13-13
			CAGE GLENOID, CEMENTED,Mates with 47, 50, 53 head, beta curvature,Medium
			10885862172693314-13-14
			CAGE GLENOID, CEMENTED,Mates with 47, 50, 53 head, beta curvature,Large
			10885862172716314-13-15
			CAGE GLENOID, CEMENTED,Mates with 47, 50, 53 head, beta curvature,Extra Large
			10885862172723314-13-22
			CAGE GLENOID,POSTERIOR AUGMENT, CEMENTED,Mates with 38, 41, 44, 47 head, Left, Small
			10885862196163314-13-23
			CAGE GLENOID,POSTERIOR AUGMENT, CEMENTED,Mates with 41, 44, 47, 50 head, Left, Medium
			10885862196170314-13-24
			CAGE GLENOID,POSTERIOR AUGMENT, CEMENTED,Mates with 44, 47, 50, 53 head, Left, Large
			10885862200983314-13-25
			CAGE GLENOID,POSTERIOR AUGMENT, CEMENTED,Mates with 44, 47, 50, 53 head, EXTRA LARGE,Left
			10885862200990314-13-32
			CAGE GLENOID,POSTERIOR AUGMENT, CEMENTED,Mates with 38, 41, 44, 47 head, Right, Small
			10885862201003314-13-33
			CAGE GLENOID,POSTERIOR AUGMENT, CEMENTED,Mates with 41, 44, 47, 50 head, Right, Medium
			10885862201010314-13-34
			CAGE GLENOID,POSTERIOR AUGMENT, CEMENTED,Mates with 44, 47, 50, 53 head, Right, Large
			10885862201027314-13-35
			CAGE GLENOID,POSTERIOR AUGMENT, CEMENTED,Mates with 44, 47, 50, 53 head, EXTRA LARGE,Right
			10885862201034320-36-00
			REVERSE SHOULDER,36mm Humeral Liner,+0mm
			10885862086617320-36-03
			REVERSE SHOULDER,36mm Humeral Liner,+2.5mm
			10885862086624320-36-10
			REVERSE SHOULDER,36mm Constrained Humeral Liner,+0mm
			10885862086631320-36-13
			REVERSE SHOULDER,36mm Constrained Humeral Liner,+2.5mm
			10885862086648320-38-00
			REVERSE SHOULDER,38mm Humeral Liner,+0mm
			10885862086655320-38-03
			REVERSE SHOULDER,38mm Humeral Liner,+2.5mm
			10885862086662320-38-10
			REVERSE SHOULDER,38mm Constrained Humeral Liner,+0mm
			10885862086679320-38-13
			REVERSE SHOULDER,38mm Constrained Humeral Liner,+2.5mm
			10885862086686320-40-00
			Humeral Liner
			10885862535030320-40-03
			Humeral Liner
			10885862535047320-40-10
			Constrained Humeral Liner
			10885862535054320-40-13
			Constrained Humeral Liner
			10885862535061320-42-00
			REVERSE SHOULDER,42mm Humeral Liner,+0mm
			10885862086693320-42-03
			REVERSE SHOULDER,42mm Humeral Liner,+2.5mm
			10885862086709320-42-10
			REVERSE SHOULDER,42mm Constrained Humeral Liner,+0mm
			10885862086716320-42-13
			REVERSE SHOULDER,42mm Constrained Humeral Liner,+2.5mm
			10885862086723320-44-00
			Humeral Liner
			10885862538413320-44-03
			Humeral Liner
			10885862538420320-44-10
			Constrained Humeral Liner
			10885862538437320-44-13
			Constrained Humeral Liner
			10885862538444320-46-00
			REVERSE SHOULDER,46mm Humeral Liner,+0mm
			10885862086730320-46-03
			REVERSE SHOULDER,46mm Humeral Liner,+2.5mm
			10885862086747320-46-10
			REVERSE SHOULDER,46mm Constrained Humeral Liner,+0mm
			10885862086754320-46-13
			REVERSE SHOULDER,46mm Constrained Humeral Liner,+2.5mm
			10885862086761

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 DICE@fda.hhs.gov or call 800-638-2041 or 301-796-7100.

                                                                                  Content current as of:
      01/16/2024
              
              
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