On February 7, 2022, Exactech announced a class II recall of their Ultra-High Molecular Weight Polyethylene (UHMWPE) Knee and Ankle Polyethylene Inserts packaged in vacuum bags. The reason for the recall was the out-of-specification vacuum bags, which could cause injury to patients who have been fitted with these inserts. The recall followed reports of premature wear leading to early revision surgery.The Exactech recall involves all knee and ankle arthroplasty polyethylene inserts packaged in non-conforming vacuum bags. The vacuum bags, which did not conform to required specifications, may cause injury to patients, which may require revision surgery.The recall, which is categorized by the U.S. Food and Drug Administration (FDA) as a class II recall affects a range of knee and ankle implants packaged in the non-conforming vacuum bags since 2004. These include components from the following implant systems:
OPTETRAK® All-polyethylene Tibial Components
OPTETRAK® Tibial Inserts
OPTETRAK Logic® Tibial Inserts
TRULIANT® Tibial Inserts
VANTAGE® Fixed-Bearing Liner Component
Reports from Exactech reveal that approximately components in the OPTETRAK® and OPTETRAK Logic® range account for over 80% of the total recalled products already implanted in U.S. patients since 2004. The VANTAGE® range which was introduced in the U.S. market in 2016 accounts for less than two percent of the total implanted units being recalled. Patients who are not sure whether they received an implant affected by the recall are advised to contact their surgeon who can make a determination based on the serial number of the patient’s implant. Patients who have the serial number for the implant they received can also visit the
online platform created by Exactech to check if their implant is affected by the recall.
Signs Your Exactech Knee or Ankle Implant has Failed Some patients who received a recalled implant between the years of 2017 and 2022 may have received a letter from their surgeon informing them of the recall and alerting them to some symptoms of implant failure.
Doctor examining woman’s foot; image by Marlon Lara, via Unsplash.com.
However, any implant patient experiencing the following symptoms should not wait to receive a letter from their surgeon to seek medical assistance:
New or worsening ankle swelling
New or worsening knee swelling
Pain while walking
Inability to bear weight
Grinding or other noise in the knee or ankle
Instability
Clicking in your knee or ankle
These could be signs that your ankle or
knee implant has failed. To make a final determination on the condition of your insert, your surgeon will conduct a physical examination and obtain x-rays. The results of your surgeon’s evaluation of your symptoms and the results of your x-rays, will determine what further action is required in your case. Revision surgery may be recommended if you are experiencing pain and any other symptoms.
Am I Eligible for an Exactech Lawsuit?You may be eligible for an Exactech lawsuit even if you did not receive a letter from your surgeon, or you already had revision surgery prior to the announcement of the recall. As long as you were treated with one of the recalled products, you may still have a valid defective device claim against Exactech.Exactech has offered to reimburse patients for certain out-of-pocket costs related to clinical follow-up and any revision surgery that may be necessary. They have retained Broadspire as the claims processor for these reimbursements. Patients who wish to make a claim for reimbursement through Broadspire can call the Exactech-Broadspire Helpline to start the process. You should speak to a lawyer before you make a claim through Broadline because you may be entitled to more compensation than Exactech is offering. Depending on your circumstances, you damages may include:
Although no lawyer can determine the specific value of your case, a defective devices lawyer will be able to assess your case and tell you what damages you may be entitled to.
