What You Need to Know
In March, 2015, the U.S. Food and Drug Administration issued a recall notice governing the Persona Trabecular Metal Tibial Plate, manufactured by Zimmer Biomet, a small company in Indiana. The recall is the fourth one issued since 2010 on a Zimmer product. The FDA took its action after more than 1,000 lawsuits were filed alleging faulty design in the Zimmer products.
The Specific Problems with the Persona Trabecular Metal Tibial Plate (PTMTP)
The PTMTP is designed to be used without any type of cement, but to properly fixate to the bone anyway. Zimmer has also designed a number of components that can be used with it, so that it closely replicates the natural knee.
The initial complaints about the PTMTP involved concerns about components that became loose, or about gaps between a component and the existing bone, or between components. Over time, these gaps can accumulate joint fluid, tissue or debris, causing damage to existing bone, and leading to implant failure. When then implant fails, it can lead to serious injury, including nerve damage, fractures, dislocations, swelling and joint pain, and loss of mobility.
Experts say that some loosening of components is inevitable over time, but that it typically takes several years. In some of the lawsuits filed against Zimmer, knee transplant recipients alleged that the implant failed in less than a year. Zimmer has publicly pointed the finger at surgeons, even though studies show that the Zimmer products as a whole fail at a higher rate than other knee implants. One doctor reported a loosening of components in 36% of patients.
Contact Our Office
For a free initial consultation, contact our office online or call us at 973-993-8787. We have office locations in Morristown and Newton, but will visit you in your home or the hospital, if necessary.