According to consumersafety.org, the Zimmer Biomet Company is no stranger to difficulties surrounding its manufacturing of hip and knee prosthetic units and components.

The Zimmer Persona knee recall, initiated in January and announced by the Food and Drug Administration (FDA) in March of 2015, is just one of many post-marketing and distribution actions taken by the company for damage control.

The Persona knee prosthesis was approved late in the year 2012 through the 510(k) program of the FDA. This program allows medical device and pharmaceutical companies to push a new product through the approval process without significant clinical testing data if it can be proven the item is substantially similar to something already on the market.

In the case of the Zimmer Persona knee recall and other prosthetic recalls, this program’s viability might seem to be in question.

Total Knee Replacement Rates

Total knee replacement recipients in the U.S. numbered at least 4.4 million as of the year 2013. In a successful knee replacement surgery – which orthopedic surgeons generally opt to delay as long as possible – an artificial joint can be expected to last up to 20 years.

Usually 8-10 years into this period, a revision surgery is needed to replace the artificial meniscus, a faux cartilage cushion made of polyethylene.

Prior to the manufacturer initiating the Zimmer Persona knee recall, however, an unusually large number of patients reported experiencing complications that led to early revision and new prosthetic implantation.

 Zimmer Persona Knee Recall One of Many Problems for Company

Although Zimmer Biomet has been in business since 1927 operating out of Warsaw, Ind., and generally has a favorable reputation among medical device developers and manufacturers, it has had to issue recalls on a number of its prosthetic components and units.

In addition to the Zimmer Persona knee recall affecting 11,658 distributed units of the Persona Trabecular Metal Tibial Plate, the company has issued recalls on the following prosthetic components since November 2014:

• Persona Tibial Articular Surface Inserter
• Persona anterior referencing sizer with locking boom
• PRI femoral impactor block
• Natural Knee II revision femoral stem
• NexGen System REF 5980-37-01 tibial component size stemmed 3 precoat
• Persona Personalized Knee System articular surface posterior stabilized (PS) left
• NexGen knee system components

Why are Knee Replacements Done?

Knee replacement surgeries or knee arthroplasty surgeries are typically done for one of several reasons including age-related wear and tear, damage from obesity or necrosis of bone tissue in the knee, and hereditary conditions developing over time such as arthritis, osteoarthritis, rheumatoid arthritis, or developmental abnormalities.

There are also cases in which several repeated injuries may bring on the need for joint replacement surgery. These injuries can be from sports, car accidents and any one of a number of other sources.

Problems Which Brought on the Zimmer Persona Knee Recall

With the Zimmer Persona knee prosthesis, complaints came pouring in shortly after FDA approval. Recipients were experiencing severe pain and inflammation often leading them back to see their orthopedic surgeons.

Radiolucent lines were often discovered upon X-ray, which were big signs that the implant was loosening. The eventual result would be the need for early revision surgery.

Radiolucent lines are small spaces or crevices where excess intracellular fluid can get trapped, as well as metal debris caused by a breakdown of the metal knee itself. If there were no surgical intervention, this situation could cause the bone tissue to become necrotic and die.

If you were the recipient of a Zimmer Persona knee implant and have suffered as a result, consider requesting a free consultation with one of our expert product liability lawyers to see if you qualify for compensation.