Exactech Knee Implant Failure
Exactech Knee Implant Failure. Plastic polyethylene inserts with 147,732 recalled Exactech knee implant devices may degrade prematurely causing failure rates 3 to 7 times higher than other total knee replacement systems.
What is Involved in a Total Knee Replacement (TKA)?
During the TKA procedure, the surgeon makes a cut on the front of the leg over the knee. The surgeon then prepares the femur portion of the knee, the distal femur, removes any diseased bone and drills a hole in the femur in which to implant the femoral component of the device. The surgeon will then place a femoral implant onto the distal femur using surgical cement.
Next, the surgeon will prepare the proximal tibia, the bone located at the bottom of the knee. The tibial preparation includes removing diseased bone, and drilling a hole in which to implant the tibial tray. The tibial tray is then implanted using surgical cement.
A third product, the tibial insert, is a polyethylene product implanted between the femoral implant and tibial tray.
Scope of the Exactech Knee Implant failure
A huge recall has begun for more than 140,000 Exactech knee implant replacement devices implanted in the United States since 2004. The Exactech knee implant replacement devices, have a defectively packaged polyethylene insert that may cause the knee implants to fail prematurely, resulting in the need for additional painful and expensive surgery.
Exactech is a medical device manufacturer based in Gainesville, Florida, and 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.
The Exactech Optetrak knee replacement system was approved for sale through the FDA’s notorious 510(k) fast-track process. Under this fast track approval process Exactech knee implants did not have to undergo extensive testing for safety and effectiveness, but only needed to show that the device was “substantially equivalent” to existing knee implants.
What’s the Problem with the Exactech Knee Implant?
The Exactech Optetrak knee replacement system was first sold in the United States in 1994. Exactech may have incorrectly packaged the plastic polyethylene insert. This defective packaging allows the plastic inserts to oxidize before they are implanted, causing the component develop micro fractures and cracks leading to premature failure, or become damaged once implanted.
As a result of the Exactech knee failure, patients may develop severe knee pain, swelling or joint instability, pain on walking or difficulty to weight bear. Some patients experiencing Exactech knee failure note knee grinding, and clicking, leading to knee revision surgery or procedures to replace the worn out plastic polyethylene insert.
The Scope of the Exactech Knee Implant Recall
The Exactech knee implant recall involves 60,926 Exactech Optetrak knee implants, 60,518 Exactech Optetrak Logic knee implants and 24,727 Exactech Truliant knee implants.
National Registries Confirm Higher Failure Rates with Exactech Knee Implants
Data submitted to national joint registries maintained in Australia, United Kingdom and New Zealand have confirmed that the Exactech Optetrak knee failure rates are substantially higher than what is seen with other total knee replacement systems. The overall rate of knee replacement failures with Exactech Optetrak were two-times higher.
The rates of knee replacement and revision surgery involving premature polyethylene insert failure, there is a three to seven fold failure rate when compared to other manufacturers.
Exactech Optetrak Knee Lawsuits
Recently, several Exactech Optetrak knee lawsuits have been filed by patients who complained of premature failure, noting that the knee implants had a horrendous failure rate.
EXACTECH KNEE RECALL LAWSUITS. Did you or a loved one experience problems with an Exactech Optetrak, Optetrak Logic or Truliant knee replacement? Dr. Shezad Malik law firm based in Dallas, Texas is now reviewing Exactech knee implant failure and revision cases nationwide. Please call 214-390-3189 or email us for further information.
Exactech, Knee Implant, Knee Implant Recall, Knee Replacement System, Optetrak.