Exactech Knee, Hip, and Ankle Replacement Recall

Exactech identified the several devices it manufactured and sold from 2004 through 2022 as containing materials that may be defective and could cause them to fail. The following knee, ankle, and hip replacements are recalled:

• OPTETRAK Partial & Total Knee Replacements:
  • All-polyethylene CR Tibial Components
  • All-polyethylene PS Tibial Components
  • B-Series Ps Tibial Insert
  • CC Tibial Inserts
  • CR Tibial Inserts
  • CR Slope Tibial Inserts
  • PS Tibial Inserts
  • CUSTOM OPTETRAK Angled PS Insert
  • CUSTOM OPTETRAK CC Tibial Insert
  • HI-FLEX® PS Tibial Inserts
  • HI-FLEX® PS Tibial Inserts
  • RBK PS Tibial Components
• Exactech OPTETRAK Logic Total Knee Replacements:
  • CR Tibial Inserts
  • CR Slope Tibial Inserts
  • CRC Tibial Inserts
  • PS Tibial Inserts
  • PSC Tibial Inserts
  • CC Tibial Inserts
• Exactech Truliant Logic Total Knee Replacements:
  • CR Tibial Inserts
  • CR Slope Tibial Inserts
  • CRC Tibial Inserts
  • PS Tibial Inserts
  • PSC Tibial Inserts
• Exactech Vantage Total Ankle Replacement:
  • Fixed-Bearing Liner Component
• Total Hip Replacement Liner:
  • Exactech Connexion GXL polyethylene liner

If you are unsure which component you have, you may request this information from your surgeon. Specifically, ask for the Product ID Sticker and operative report.

Notice of a Class II recall of the knee and ankle products was issued by Exactech on February 7, 2022. Surgeons, hospitals and health care professionals received the notice. It informed them of early deterioration of the polyethylene components that may require surgical removal of defective devices. A separate letter went out to surgeons in June 2021, indicating the Connexion GXL acetabular liner may fail early.

Exactech claims it discovered (through testing) that polyethylene components used in the total ankle, hip, and knee replacement systems were packaged and stored in “non-conforming” vacuum bags. The purpose of the bags was to limit exposure of the polyethylene or plastic components while in storage to prevent deterioration due to exposure to oxygen.

The company says the vacuum bags were non-conforming because they did not contain a secondary barrier to increase resistance to oxygen. In return, this causes deterioration of the plastic components during storage. As a result, total knee, ankle, and hip manufactured between 2004 and 2022 using plastic components may not have been properly protected during storage. This can cause patients to experience premature wear of the plastic components and an increased risk of bone loss. The Exactech Connexion GXL polyethylene liner was taken off the market in 2019.

The recall notification referred to several clinical issues that could arise from deterioration of the polyethylene, including:

• Mechanical failure.
• Loosening of the device.
• Device fracture.
• Pain.
• Bone loss.
• Swelling of the affected area.

Exactech recalled all of its knee and ankle devices manufactured with polyethylene components using the non-conforming packaging. The Florida-based company also directed surgeons not to use the devices for future surgical procedures.

The notice sent to surgeons recommends against removing an Exactech device absent evidence of its failure as long as it functions properly and is not causing pain or discomfort to a recipient. The company advised physicians company to monitor patients who complain of any of the following symptoms:

• Knee or ankle instability.
• Weight-bearing issues.
• Noises, including grinding sound, emanating from the joint.
• Swelling or complaints of pain.

Additionally, Exactech advised surgeons to evaluate recipients of the devices for potential wear, osteolysis or bone loss, and other signs of failure. The company also recommends physicians use X-rays to assist in evaluating device failure. This testing can help regardless of the product’s shelf life and regardless of how much time has elapsed since the replacement surgery. If you have a recalled device, don’t delay in seeking legal representation. Time is of the essence. Contact The Ruth Law Team today for a free case evaluation.