More than 600,000 knee replacements are performed each year in the US. The DePuy Synthesis Attune knee, approved by the FDA in 2010 is the most commonly utilized Total Knee Replacement (TKR) implant since it first came to market in 2013.
As of June 2017, the FDA had already received more than 1,400 Adverse Event Reports with respect to early implant failure in the form of instability and/or warmth or heat in the knee, unusual swelling, dislocation or misalignment of parts, loosening of the knee replacement parts, persistent pain, and fractures of the bones (typically the tibia) around the knee replacement. Of those, nearly 50% were instances where individuals were required to have revision surgery.
In a 2017 study published in the Journal of Knee Surgery, researchers noted a significant increase in DePuy Attune knee tibial loosening and failures, raising concerns about the cement interface between the implant’s tibial baseplate and the patient’s tibia.
Though to this point plaintiffs’ firms have yet to petition the JPML to consolidate Attune Knee claims, based on the incidence rate it is believed that more than 10,000 Americans are currently dealing with painful and potentially life-threatening issues related to the TKR implant failures.
Important Links:
- https://www.thieme-connect.de/products/ejournals/abstract/10.1055/s-0037-1603756