Exactech Hip Replacement Recall Lawsuit

Exactech issued a voluntary recall of their hip replacement implants due to defective manufacturing. The U.S. Food & Drug Administration posted the recall notice on July 22, 2021.

On Mar. 23, 2023, the FDA issued a reannouncement of recalled Exactech medical device products. The majority of the recalled joint replacement devices (knees, ankles and hips) were defectively packaged. The bags were missing an oxygen barrier intended to protect against oxidation.

Why were the hip implants recalled?

Exactech, a global medical device company, recalled their Connexion GXL & Conventional Hip Liners due to defective components in the devices.

Defective manufacturing of the hip implants can cause early degradation and total joint failure. Degradation can lead to osteolysis, a progressive condition that weakens bone tissue.

The firm initiated the recall of their joint replacement products on June 29, 2021.

There is an estimate of over 147,000 Exactech hip, knee and ankle replacements implanted since 2004.

According to Exactech, Inc.:

”During a recent review of its hip implant manufacturing process, Exactech learned that these polyethylene inserts can potentially become oxidized prior to and after implantation into the body. Oxidation is a natural chemical process that occurs when materials are exposed to the oxygen in the ambient air. In the case of these Exactech hip polyethylene inserts, the oxidation levels in the plastic are higher than desired. If a large amount of oxidation takes place prior to and after the plastic liner is implanted into the patient’s hip joint, it can cause the plastic to wear out earlier than expected or to become damaged after it is implanted into the patient’s body.

Exactech has recently observed that in a small percentage of patients, the plastic liner has worn out earlier than expected. Premature wear of the plastic insert of your hip replacement can lead to the need for additional surgery (also known as revision surgery). In those cases where the plastic has worn out earlier than expected or has been damaged, we will evaluate your hip replacement and decide whether additional treatment is needed. Determination of whether the plastic is worn is accomplished by examining your hip in the office and obtaining x-rays. After this evaluation is complete, we will decide if additional treatment, including revision surgery, is necessary.”

What symptoms can a patient experience with these recalled products?

Patients with an implanted Exactech hip replacement can experience:

• New or worsening pain while walking
• Lack of stability
• Pain while bearing weight
• Swelling in or around the impacted joint
• Clicking or grinding noises and/or sensations from the joint
• Joint dislocation
• Buttock pain
• Thigh pain
• Groin pain
• Pain in knee of affected hip

Explanation of Exactech Hip Replacement Recall

According to Exactech’s patient letters regarding the recalls, most standard hip replacements consist of four parts:

• Acetabular metal shell – The hip socket
• Acetabular liner – Cushion for damaged cartilage
• Femoral head – Ball of hip joint
• Femoral hip stem – Component in thigh bone securing the femoral head

Related Content:

• Exactech Ankle Lawsuit
• Exactech Knee Lawsuit