Portions of the Zimmer Persona total knee replacement system is being recalled by its manufacturer. In February 2015, Zimmer, a leading orthopedic company, notified customers of its Class 2 FDA recall. The knee replacement system by Zimmer was the primary driver in increased sales for the company in 2014.
The recall affects more than 11,500 patients worldwide. The move by Zimmer and the FDA is expected to produce a negative profit outcome for the company.
The orthopedic company’s Persona Trabecular Metal Tibia Plate is being recalled because of increasing “complaints of radiolucent lines and loosening.” Apparently, the unit’s design creates an ineffective “seat for the plate” that can produce poor patient outcomes because it can generate significant knee pain.
The FDA (Food and Drug Administration) disclosed Zimmer’s issued recall notice in March 2015. The released disclosure stated a recall notice was sent to healthcare providers and hospitals on February 16, 2015 with directions to locate and quarantine all effective knee products immediately.
A Class 2 recall is issued when products cause medically reversible or temporary adverse consequences to a patient’s health. However, the medical problems associated with the knee replacement system still have the potential of causing multiple complications.
A Competitive Market
Zimmer has been developing total knee replacement systems since 1968. This includes the 1995 release of the NexGen Complete Knee Solution System. In 2013, the orthopedic company brought their Persona knee replacement system to market in an effort to capture a share of business enjoyed by more than six competing knee systems from other manufacturers.
The device secured Zimmer’s position in the knee replacement medical marketplace.
Doctors have used the Persona because of its advantage over competitive devices since it provides a more accurate anatomical fit for both right and left knees of varying sizes. By the end of 2014, Zimmer generated approximately $2 billion in net sales from all of his knee related products. While sales had decreased in 2013 by four percent, it increased upwards of more than two percent the following year.
Loosening and Bone Damage
The Trabecular Metal Tibia Plate is designed to be installed without the use of cement while still providing an optimal fixation to the patient’s bone. Surgeons have chosen the implant because it easily adapts to a variety of surgical styles to provide an outcome quite similar to a natural knee.
Within the first year of use, Zimmer reported receiving increasing complaints of radiolucent lines (gaps between components) and an overall loosening of the implant. The problem occurred because that part of the implant was not properly secured.
Over time, the gap can become filled with debris, tissue or joint fluid causing the implant to become significantly loose before failing. Some patients receiving the device have developed bone damage (osteolysis).
In many cases, the significant health problems generated by radiolucent lines require revision surgery as a way to correct the issue. Usually, the implant needs to be replaced. If the implant has become loose, the patient often experiences a variety of common symptoms including knee pain, knee stiffness, limping, and challenges when placing even minimal weight on the leg and foot along with a diminished range of motion in the knee joint.
Zimmer’s Ongoing Problem
There has been a significant rise of lawsuits filed against Zimmer for the many different medical devices they manufacture. Some recalls have triggered legal action taken by mass tort law firms in an effort to provide financial recovery for patients seriously harmed by the medical product.
Because of the recall caused by complications associated with the Zimmer total knee replacement device, patients injured by the allegedly defective component are likely entitled to seek financial compensation. Individuals that have received the implant and are experiencing unexplained pain and discomfort in the knee will likely require revision surgery.
If you are suffering injuries, pain or discomfort from your Persona replacement knee implant, it is essential to contact your physician immediately to safeguard your health. To ensure your rights are protected, it is essential to seek advice and legal counsel on how to file a claim for compensation. Personal injury lawyers can start the process of helping you receive recompense for the injuries you suffer because of your defective Zimmer knee implant.
If you have any legal questions and need advice, contact a Chicago Medical Device Defect Attorney today.