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Zimmer Knee Replacement Recall

Zimmer Holdings produces thousands of different types of orthopedic devices, trauma devices and dental implants. From humble beginnings in 1927 as a manufacturer of aluminum splints, the company grew to become one of the top medical device manufacturers in the world, with sales exceeding $4 billion in 2008 alone. The company continues to thrive today, despite reports of complications with some of their devices and a very limited Zimmer knee recall.

Orthopedic devices, including knee implants, have become a Zimmer specialty. The company produced its first knee implant in 1968 and its first knee prosthesis in 1973. Today, the company has become the largest manufacturer of knee implant devices in the world, garnering a 26-percent market share in this area.

In 1999, the company introduced the Zimmer NexGen knee replacement system. The NexGen system was originally touted by the company as an excellent alternative for the younger, more active patient, due to their durability and increased range of motion. Unfortunately, the NexGen system has also received a number of reports linking the device to a high failure rate and a myriad of painful complications.

Zimmer knee complications noted by orthopedic surgeon

Dr. Richard Berger, a noted orthopedic surgeon and consultant for Zimmer, began using the Zimmer device for knee implant surgeries in his own patients. However, Dr. Berger noticed a high rate of complications among his patients who received the implant, with more than one-third experiencing significant loosening of the joint. In addition, more than eight percent of Dr. Berger’s patients required revision surgery just two years after their initial procedure, despite the fact that knee replacements were supposed to last 10-15 years.

Dr. Berger published his findings in a 2010 report titled, “The High Failure Rate of a High-Flex Total Knee Arthroplasty Design.” The report was presented at a meeting of the American Association of Orthopedic Surgeons. In response to the report, Zimmer attributed Dr. Berger’s high rate of failure to his surgical technique and failed to issue a recall for the specific NexGen device listed in Dr. Berger’s report at that time.

Complications associated with Zimmer knee replacement

The Zimmer NexGen system includes a variety of components that can be used in various combinations for the purpose of customizing the device to the specific needs of the patient. However, some of the components used in these systems have been associated with potentially serious and debilitating complications.

Patients with various Zimmer knee models complain of:

  • Chronic pain after surgery
  • Device loosening, leading to the need for repair
  • Clicking and popping sounds from the implant site
  • Knee swelling and pain
  • Difficulty walking, resulting in reduced mobility
  • Need for revision surgery within a few short years

Revision surgery can be a risky procedure for those who recently had their original knee replacement surgery. According to the American Academy of Orthopedic Surgeons, knee revision surgery carries a higher risk of malpositioning of the components, as well as loosening of the joint. Revision surgery also results in higher medical costs and a second rehabilitation process, which could mean more lost wages for the patient.

The FDA has received hundreds of reports regarding these complications with the NexGen systems. Zimmer sent a Dear Doctor letter to orthopedic surgeons throughout the U.S. in April, 2010, to explain modified surgical techniques for implanting components of the NexGen system. At the time, Zimmer held to its assertion that complications stemming from the device were to be attributed to surgeon error and not a defect with the system itself.

Although the company issued a voluntary, though limited, class II recall in 2010 of the NexGen Complete Knee Solution MIS tibial component parts in response to adverse event reports, the device continues to be marketed to the medical community and general public today.

The FDA issued another Zimmer knee recall of the NexGen LPS femoral components later that same year. Like the previous action, this recall affected only a minimal number of devices due to a specific defect that was swiftly repaired. Zimmer continues to deny any possible defect with their knee replacement components, citing surgical technique as the cause of complications and early failure.

Zimmer devices receiving complaints

While Zimmer manufactures a number of different devices for knee implant surgery, three of those devices have received attention for their relatively high rate of complications and early failure.

Those devices include:

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

Zimmer knee litigation begins to grow

Although Zimmer has repeatedly denied any defects with their products, some patients who have been injured by Zimmer knee replacement devices have filed lawsuits against the company. Plaintiffs were seeking compensation for medical bills, lost wages and pain and suffering, claiming the company did not adequately warn patients and the medical community about potential risks associated with their devices. Hundreds of lawsuits have now been filed against the company in courtrooms around the country.

In August, 2011, federal lawsuits against Zimmer were coordinated into multidistrict litigation in U.S. District Court for the Northern District of Illinois.

A number of Zimmer NexGen components have been named in this litigation, including:

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

Judge Rebecca Pallmeyer has been assigned to oversee the MDL, which was established to streamline early trial proceedings, prevent duplicate discovery and make litigation more convenient for both plaintiffs and defendants. Currently, there are more than 1,000 plaintiffs awaiting litigation in those proceedings.

Those who are still considering legal action are encouraged to retain an experienced Zimmer knee lawyer who is well-versed in product liability litigation.

  1. New York Times, Surgeon vs. Knee Maker: Who’s Rejecting Whom?
  2. FDA, Class II Recall, NexGen Complete Knee Solution MIS Tibial Components, Locking Screw and Stem Extensions,
  3. U.S. District Court, Northern District of Illinois, Master Docket for MDL No. 2272,
  4. Modern Healthcare, Zimmer’s Legal Challenge,
  5. American Academy of Orthopedic Surgeons, Joint Revision Surgery – When do I Need It?