The medical device company, Exactech, has expanded its recall of some of its knee and ankle medical implants due to improper vacuum sealed bags that did not meet specifications. The products were packaged without an additional layer of ethylene vinyl alcohol that further augments oxygen resistance.
According to the notice released by Exactech:
“The use of these non-conforming bags may enable increased oxygen diffusion to the UHMWPE (ultra-high molecular weight polyethylene) insert, resulting in increased oxidation of the material relative to inserts packaged with the specified additional oxygen barrier layer. Over time, oxidation can severely degrade the mechanical properties of conventional UHMWPE, which, in conjunction with other surgical factors, can lead to both accelerated wear debris production and bone loss, and/or component fatigue cracking/fracture, all leading to corrective revision surgery.”
If you received a total knee replacement or an ankle replacement since 2010, with components or inserts manufactured by Exactech, your physician should have reached out to you. However, if you are not sure about your medical device, you should contact your physician to determine if your device is affected by the recall.
The defective components affected by the Exactech recall include the following:
- OPTETRAK® All-polyethylene Tibial Components
- OPTETRAK® Tibial Inserts
- OPTETRAK Logic® Tibial Inserts
- TRULIANT® Tibial Inserts
- VANTAGE® Fixed-Bearing Liner Component
To see all products involved in the recall, click here.
The symptoms to be aware of should you have a defective Exactech Knee or Ankle device are:
- Ankle swelling
- Knee swelling
- Pain in the joint while walking
- Grinding or clicking noise from the implant
- Instability or inability to bear weight on the leg
Your surgeon will examine you and conduct tests such as x-rays to determine the condition of your Exactech knee or ankle device and will then make a recommendation if a revision surgery is needed. Contact us for a free, legal consultation if you are concerned about your Exactech medical device.