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Information for HSS Patients about the Exactech Recall  - logo image

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.

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 is contacting affected patients

HSS has sent multiple notifications to all of its patients impacted by the Exactech knee and ankle implant  recall, 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.

HSS is in the process of notifying all of its hip patients impacted by the Exactech recall. If you are affected by this hip implant recall and your HSS surgeon’s office has your current contact information, you will receive notification from HSS. If you think you are affected by this Exactech recall but have not received notification from HSS, please complete this form and an HSS patient access specialist will contact you.

Explanation of the Exactech recall

As shown in the diagram below, a standard knee replacement has four parts:

  1. Femoral component - this is the metal piece that attaches to the thigh bone, also known as the femur.
  2. Tibial tray - this is the metal piece that fits into the shin bone, also known as the tibia.
  3. Patellar component - this is the piece of plastic that fits onto the kneecap, also known as the patella.
  4. 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.

components of Exactech knee replacement

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.

As shown in the diagram below, a standard ankle replacement has three parts:

  1. Tibial component - this is the metal piece that attaches to the shin bone, also known as the tibia
  2. Talar component - this is the metal piece that fits into the foot bone, also known as the talus
  3. 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

components of Exactech knee replacement

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.

As shown in the diagram below, most standard hip replacements contain four critical parts:

  1. Acetabular metal shell (this is the metal “socket” that goes into your native hip socket)
  2. Acetabular liner (plastic / polyethylene) liner (this is the new “cushion” that replaces the damaged cartilage).
  3. Femoral head (this is the new ball of your hip joint, usually made of ceramic or metal).
  4. Femoral hip stem (this is the component that fits into your thigh bone and secures the new ball).

components of Exactech hip replacement

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 HSS at the number corresponding to your surgery:

Knee or ankle surgery: 212.606.1444 (Mon-Fri, 9am - 5pm ET)

Hip surgery: 1.855.532.1778 (Mon-Fri, 9am - 6:30pm ET)

Or you can complete a brief form. A patient access specialist will reach out to you and if appropriate, refer you for a clinical evaluation and other testing such as an X-ray, if necessary.

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 onsite

HSS Patient Access

We understand you may have questions and concerns. We are here to assist.

Knee or ankle surgery: call 212.606.1444 (Mon-Fri, 9am - 5pm ET)

Hip surgery: call 1.855.532.1778 (Mon-Fri, 9am - 6:30pm ET) 

Or fill out our form and an HSS patient access specialist will contact you right away.

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.