Zimmer Knee Replacement Recall

When Zimmer was founded in 1927, the company was a small aluminum splint manufacturer in Indiana. Today, Zimmer Holdings is a multinational, publicly traded medical device company that makes dental implants, spinal and trauma devices, and orthopedic surgical and reconstructive devices. In 2008, Zimmer Holdings grossed sales of over $4.21 billion.

Orthopedic medical devices and products are Zimmer’s strength, and the company is currently the largest producer of knee replacement components. Zimmer reportedly controls 26 percent of the international knee replacement market, which has an estimated worth of $7.2 billion.

But while the company is considered the most important manufacturer of knee replacements today, Zimmer has also faced great challenges. In the 21st century alone, the company’s knee implants have garnered hundreds of official complaints to the U.S. Food and Drug Administration (FDA), while orthopedic surgeons and industry experts have reported exceptionally high failure rates. These complaints have led to various Zimmer knee replacement recalls of certain devices, as well as many lawsuits against the manufacturer.

Zimmer’s most popular knee replacements among most problematic

In 1995, Zimmer produced the NexGen Complete Knee Solution System, a popular choice for total knee replacement. In 2001, the company announced a new knee replacement system, known as the NexGen Flex line. The NexGen Flex line of products is comprised of several different components, which may be implanted in whole or in part.

As with any major surgery, total knee replacements are associated with risks and a range of possible complications including poor range of motion, unexplained pain, swelling and infection. Properly functioning devices should have a low rate of complication. Serious problems arise when a device, or entire product line, is linked to higher-than-average rates of side effects.

Unfortunately for Zimmer, patients and medical professionals report high complication rates for several of the company’s devices.

The three most common products linked to adverse event reports and litigation are:

• Zimmer NexGen CR-Flex femoral components
• Zimmer NexGen MIS Tibial components
• Zimmer NexGen LPS-Flex femoral components

Complications reported by Zimmer NexGen knee recipients

Thousands of patients around the globe have been implanted with components from Zimmer’s NexGen product line, with many reporting many serious side effects.

Some of the most common complaints include:

• Device loosening: NexGen component parts loosen, causing further complications and requiring repair.
• Chronic pain: Unexplained, persistent pain following surgery
• Reduced mobility: Pain or difficulty walking; the inability to stand for long period of time
• Popping and clicking: Strange sounds emanating from the implant site
• Swelling: Severe swelling around the knee
• Revision surgery: The need for early revision surgery, a risky procedure that often entails a more difficult recovery 

Prominent knee surgeon reports high complication rates

In 2010, Dr. Richard Berger, a prominent orthopedic surgeon, published a report entitled, “The High Failure Rate of a High-Flex Total Knee Arthroplasty Design.” Dr. Berger presented the non-peer-reviewed report at an American Association of Orthopedic Surgeons (AAOS) meeting, to inform the medical community of troubling observations he made with regard to a certain type of knee implant.

In the report, Dr. Berger detailed results from 108 surgeries involving NexGen CR-Flex Porous Femoral components. Some of Dr. Berger’s more prominent – and concerning – findings include the fact that 36 percent of his patients showed signs of radiographic loosening. Additionally, while knee replacements are designed to last 10 to 15 years, 8.3 percent of Dr. Berger’s patients required revision surgery within two years of their initial procedure. At the time of his report, an additional 1 percent of patients were awaiting revision surgery.

Manufacturer issues voluntary Zimmer knee recall

On April 26, 2010, Zimmer sent a Dear Doctor letter to orthopedic surgeons around the United States, detailing a modified surgical technique to implant NexGen knee components. Zimmer’s position was that any reported problems were due to surgical error, and not the device itself.

However, several months later, patient complaints continued to roll in. Following 114 FDA adverse event reports and Dr. Berger’s information, in September 2010 Zimmer issued a voluntary recall for specific NexGen Complete Knee Solution MIS Tibial component parts. The FDA classified this Zimmer knee recall as Class II, and no public announcement was made.

In December 2010, the company ordered a second Zimmer knee replacement recall, this time for Zimmer NexGen LPS femoral components. This voluntary recall affected only several hundred products, which reportedly suffered manufacturing defects.

Despite the limited application of those recalls, components not directly recalled are still available and used in knee replacement surgery today.  Zimmer firmly denies any evidence of defects within the NexGen family of products, and has continually placed the blame on surgical technique rather than a problem with its knee implant devices.

Zimmer knee replacement recall fuels multidistrict litigation

Any product recall, even a voluntary one, can spark concern in the medical community. The Zimmer knee recalls in 2010 informed the public of potential problems linked to the NexGen product line, and in turn warned affected patients that their knee complications may not be normal, run-of-the-mill side effects. As a result, many chose to file lawsuits against Zimmer, mostly to seek compensation for escalating medical bills and lifestyle changes due to allegedly faulty implants.

On August 8, 2011, federal Zimmer lawsuits were transferred to multidistrict litigation (MDL No. 2272) in the U.S. District Court for the Northern District of Illinois, assigned to Judge Rebecca Pallmeyer.

The Zimmer MDL incorporates complaints related to:

• NexGen Complete Knee Soluton CR-Flex Gender Solutions Female CR-Flex (GSF-Flex)
• All NexGen MIS Total Knee Procedure Stemmed Tibial Components
• NexGen Complete Knee Solution (LPS-Flex)
• NexGen Complete Knee Solution Cruciate Retaining-Flex Femoral Components (CR-Flex)
• NexGen Complete Knee Solution Gender Solutions Female LPS-Flex (GSF LPS-Flex)

Multidistrict litigation enables plaintiffs to pool resources and act more efficiently, but also allows each individual case to retain its rights to arguments, settlement or jury verdict.