Exactech Inc., a medical device manufacturer recalled over 140,000 polyethylene plastic inserts used in knee and ankle replacements because the plastic may wear early, leading to implant failure and revision surgery. Polyethylene is utilized to help cushion joints between metal components inside knee and ankle replacements. The implant devices may degrade prematurely causing failure rates 3 to 7 times higher than other total knee replacement systems. Exactech now admits that it has been selling defective knee implant replacement systems for almost twenty years, including Exactech Optetrak, Optetrak Logic, Truliant and Vantage makes of knee implants.
Why Are They Failing?
The company's knee and ankle devices are packaged in vacuum-sealed bags that are designed to protect the devices. The non-conforming packaging results in the devices being exposed to oxygen, which can start the process of oxidation. Oxidation can severely degrade the parts of the implant and can lead to an acceleration of bone loss, component fatigue, cracking, and/or fracture. This can commonly lead to a corrective revision surgery in the future.
The medical journal, Orthopaedics & Traumatology: Surgery & Research analyzed patients who were implanted with an Exactech total knee replacement system - and concluded that tibial loosening was a common occurrence in the cement-tibial-implant component of the device, resulting in fragmentation. The implant failure was reportedly caused by tibial insert wear and tear of the implant.
Which Devices Have Been Recalled?
The recall includes about 147,000 ankle and knee devices, all manufactured since 2004:
- OPTETRAK – about 61,000 devices implanted since 2004
- OPTETRAK Logic – about 60,600 devices implanted since 2004
- TRULIANT – about 25,000 devices implanted since 2004
- VANTAGE – about 1,200 devices implanted since 2004
If you had any of these devices implanted in recent years, there is a possibility that it was not properly packaged and may have been exposed to oxygen prior to being implanted. This may lead to oxidation of the device, which can cause the device to break down prematurely.
Those who have undergone knee or ankle replacement surgery using an Exactech total knee or ankle device should consult with their surgeon to determine the specific device used in the surgery that is included with the recent recall. If you happen to have one of these devices implanted, your surgeon can evaluate the need for corrective surgery. Defective medical device litigation helps to improve patient safety and holds medical these companies accountable when products injure plaintiffs.
If you, or someone you know, has been impacted by one of these devices and you required corrective surgery, please contact the experienced attorneys at Keilty Bonadio today for a free consultation.