Information for HSS Patients about the Exactech Recall
On February 8, 2022, Exactech, Inc., an orthopedic device company headquartered in Gainesville, Florida, USA, issued a recall of implant components used in several of its knee and ankle systems, related to Exactech’s packaging process.
Many hospitals and surgeons around the world used Exactech knee and ankle implants for replacement surgeries, including Hospital for Special Surgery (HSS). On July 22, 2022, the recall was expanded to include some of Exactech’s hip implants related to the same packaging issue as the knee and ankle components.
FDA Notification – Exactech Shoulder Implant
On January 16, 2024, the U.S. Food & Drug Administration announced 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 non-conforming packaging. Non-conforming packaging of Equinoxe Shoulder System devices was 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. 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.
HSS is not currently using any Equinoxe Shoulder Systems with non-conforming packaging, and has not detected abnormal wearing in any of the approximately 400 HSS patients who received that implant previously. HSS is monitoring the situation closely, informing all patients who received the Equinoxe Shoulder Systems implant and providing the FDA recommendations:
- 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.
Who is affected by this recall?
Most HSS implant patients are not affected by the Exactech recall. This recall affects fewer than one in five patients who received knee, hip or ankle implants at HSS between 2004 and 2021. Among patients who are affected, the failure rate of these implants is very low. HSS is committed to helping affected patients understand the signs and symptoms that may indicate the need for medical assessment and attention.
HSS has contacted all affected patients
HSS has sent notifications to its patients impacted by the Exactech knee, ankle and hip implant recalls, and engaged a leading specialist firm to operate a dedicated call center to support patients who call seeking care or information. Affected patients who have not responded to the physical mailings are being contacted by email when possible.
Explanation of the Exactech recall
Knee Implant
As shown in the diagram below, a standard knee replacement has four parts:
- Femoral component - this is the metal piece that attaches to the thigh bone, also known as the femur.
- Tibial tray - this is the metal piece that fits into the shin bone, also known as the tibia.
- Patellar component - this is the piece of plastic that fits onto the kneecap, also known as the patella.
- Tibial insert - this is a plastic insert made out of polyethylene that fits between the femoral component and tibial tray and acts as the new cushion or cartilage for the replaced knee joint.
During a recent review of its knee implant manufacturing process, Exactech learned that one of the packaging layers for the tibial insert has been out of specification and may allow oxygen from the air to diffuse into this tibial insert prior to it being implanted in a patient's knee. If a large amount of oxygen diffuses into the tibial insert while it's being stored and before it is implanted, this can lead to a process called oxidation. Oxidation can cause the tibial insert to wear out earlier than expected or to become damaged after it is implanted into the patient's body.
Ankle Implant
As shown in the diagram below, a standard ankle replacement has three parts:
- Tibial component - this is the metal piece that attaches to the shin bone, also known as the tibia
- Talar component - this is the metal piece that fits into the foot bone, also known as the talus
- Polyethylene (plastic) insert - this is the plastic insert that fits between the tibial component and the talar component and acts as the new cushion or cartilage for the replaced ankle joint
During a recent review of its ankle implant manufacturing process, Exactech learned that one of the packaging layers for the plastic insert has been out of specification and may allow oxygen from the air to diffuse into this plastic insert prior to it being implanted in a patient's ankle. If a large amount of oxygen diffuses into the plastic insert while it's being stored and before it is implanted, this can lead to a process called oxidation. Oxidation can weaken the plastic insert and cause it to wear out earlier than expected or cause it to become damaged after it is implanted into the patient's body.
Hip Implant
As shown in the diagram below, most standard hip replacements contain four critical parts:
- Acetabular metal shell (this is the metal “socket” that goes into your native hip socket)
- Acetabular liner (plastic / polyethylene) liner (this is the new “cushion” that replaces the damaged cartilage).
- Femoral head (this is the new ball of your hip joint, usually made of ceramic or metal).
- Femoral hip stem (this is the component that fits into your thigh bone and secures the new ball).
During a recent review of its hip implant manufacturing process, Exactech learned of an issue with the packaging of the plastic insert which can allow oxygen from the air into the plastic insert prior to it being implanted. If a large amount of oxygen diffuses into the plastic insert while it is being stored and before it is implanted, this can lead to a process called oxidation, which can cause the plastic to wear out earlier than expected or to become damaged after it is implanted into the patient’s body.
What should you do?
The symptoms of premature wear include unusual pain or aching, swelling, redness, stiffness, difficulty moving and/or instability.
If you do not have any of these symptoms, you can just follow-up at your regularly scheduled time interval. We expect the percentage of patients to develop any problems due to the issues identified in this recall to be very low.
If you are experiencing any of these symptoms, please contact your surgeon’s office at HSS.
Claims administration for out-of-pocket costs
Exactech is committed to addressing recall-related out-of-pocket expenses, and has partnered with Broadspire, a third-party administrator, to manage the claims reimbursement process. Please contact the Exactech-Broadspire helpline at +1.888.912.0403 to initiate the claims process. Please note that when you call the helpline, you will be asked to verify that you have received an Exactech implant included in the recall. You will also be asked for the information at the top of the letter you received from HSS: surgeon, date of surgery and insert serial number.
Additional information about these services and frequently asked questions can be found on the Exactech website at: www.exac.com/recall.
Contact Information
HSS Patient Access
We understand you may have questions and concerns. We are here to assist.
If you are seeking assistance related to the recalls, please contact your surgeon’s office at HSS or “HSS Connect” at 212.606.1555. HSS Connect can help you identify your surgeon or, if your surgeon is no longer at HSS, which surgeon you should contact.
Exactech / Broadspire
To initiate the claims process or if you have any questions regarding Exactech products or manufacturing, please call Exactech-Broadspire directly at +1.888.912.0403.