DePuy Synthes Attune Knee Implant
After numerous reports of multiple defects, Depuy Synthes, a subsidiary of Johnson & Johnson, has issued a recall for its Attune Knee system. The Attune implant bypassed the more rigorous pre-market approval process, and was fast-tracked through what is known as the FDA’s 501(k) approval process. This process means manufacturers such as DePuy need only demonstrate that their products are “substantially equivalent” to current devices on the market. DePuy had claimed that the Attune Knee System was similar to the Zimmer NexGen CR Knee system, which was recalled in 2015. Unsurprisingly, this is not DePuy’s first issued recall: From February 2003 to May 2013, DePuy recalled over 275 devices.
The Attune implant was intended to improve clinical outcomes, provide patients with greater mobility, and reduce recovery rates after knee replacement surgery. However, the implant has been linked to premature device failure, leading to multiple debilitating complications. As a result, patients currently experiencing implant failure may need to undergo revision surgery in order to remove or replace the faulty device. In addition to revision surgery, patients may also require extensive rehabilitation, at times experiencing a painful recovery.
Those with the Attune knee system currently implanted have complained of premature device failure. While some patients have experienced device failure one to two years after implant surgery, other patients experienced it only months after implant surgery. In addition to premature failure, the Attune implant can cause the following complications:
- Nerve damage
- Swelling around the knee joint
- Fracture of the device
- Fracture of the femur or tibia
- Device dislocation
- Decreased range of motion
- Metal shedding debris
If you or your loved one are a current recipient of the Attune knee implant and are experiencing any of the above symptoms, contact a New York defective medical device attorney from our firm for a free evaluation: (888) 260-0473.