Those who have had Exactech knee and ankle replacements should be aware of a recent recall by the company. The specific problem surrounds thousands of polyethylene plastic inserts due to potentially plastic wear occurring earlier than expected, resulting in failure of the implant and subsequent revision surgery.
The company admitted to packaging in “out-of-specification bags” from 2004 to the present day. Overall, nearly 150,000 devices have been implanted nationwide since that time. However, the Optetrak Knee system has been sold since 1992. Studies from outside the United States – specifically Australia, New Zealand, and the United Kingdom – reveal registries noting significantly more revision rates compared to other brands.
Specific issues surrounding the recall
The recall involves Exactech Ultra-High Molecular Weight Polyethylene Knee and Ankle Polyethylene Inserts, specifically tibial inserts and liner components. The systems include:
- Optetrak Logic
Exactech issued an Urgent Medical Device Correction letter that notified surgeons in early February, cutting packaging not fitting specifications and failing to protect inserts from oxygen exposure, speeding up degradation that results in an earlier than typical failure.
Problems that can arise include:
- Accelerated wear
- Debris production
- Bone loss
- Component fatigue/cracking
The Class 2 recall, as designated by the FDA, covers all inserts regardless of the shelf life or content on the label. The designation is for products temporarily causing or treatable health issues.
Exactech knew of the problems with Optetrak due to multiple lawsuits with plaintiffs alleging early failed implants that resulted in pain, instability, and subsequent surgery. They also contend that the company knew or should have known about the defects and should have notified consumers and stopped all sales of the defective product.