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Zimmer Seeks Dismissal of Hundreds of NexGen Cases

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In August 2011, the U.S. Judicial Panel on Multidistrict Litigation (MDL) consolidated all federal Zimmer NexGen lawsuits into one court in the Northern District of Illinois. Each of the cases transferred to the Zimmer MDL alleges problems with Zimmer’s NexGen CR-Flex, LPS-Flex, and MIS Tibial components. All of these Zimmer devices have been reported to cause premature loosening that may require revision surgery.

Since the consolidation, the court and all legal counsel have been busy with the pre-trial discovery process. Most recently, Zimmer presented arguments to Judge Rebecca R. Pallmeyer to have several hundred Zimmer knee lawsuits dismissed.

Zimmer Argues Master Complaint Too General

As is often the case in a large MDL like this one, the court allowed a master complaint that plaintiffs can use to file their cases. This complaint presents an outline of the standard claims made in Zimmer knee lawsuits, along with a list of defendants and spaces in which the plaintiff can add individual information.

On February 27, 2012, however, Zimmer filed a motion to dismiss this master complaint, stating that it is far too general to meet federal pleading standards. Judge Pallmeyer heard oral arguments on the motion June 21, 2012. An announcement concerning her decision is expected soon.

Zimmer Acknowledges Claims Against Recalled Component

Zimmer did acknowledge the complaints of one plaintiff who was allegedly injured by an MIS Tibial Component. On September 13, 2010, the FDA ordered a Class II recall of Zimmer NexGen MIS Tibial Components, TM Tibial Trays, and MIS Modular Tibial plates and keels. These components were found to have a non-conforming geometry that kept their locking screws and stem extensions from correctly interlocking with each other. At the time, Zimmer had received 114 reports of patients who had problems with these devices, including cases where the patients had to go through revision surgery because of premature loosening of the implant.

Over 68,000 products were involved in this recall, including those that had been distributed overseas. As the MIS Tibial Component can be used with either the CR-Flex or the LPS-Flex systems, many were likely implanted into patients long before the recall. The systems themselves, however, were not recalled and continue to be available today.

Zimmer also announced a recall due to manufacturing defects in December 2010, but it involved only a few femoral components used in the NexGen LPS system.

Problems Stemming from Incorrect Fusion to the Bone

In 2010, orthopedic surgeon Dr. Richard Berger, a former Zimmer consultant, issued a report showing that 36 percent of the 108 Zimmer NexGen CR-Flex implants he observed showed loosening after just two years. About 8.3 percent of them required revision surgery. The fact that the CR-Flex is not cemented to the thighbone, which was standard with older knee implants, is believed to contribute to loosening problems.

In February 2012, the Mayo Clinic presented the results of a study on the Zimmer NexGen knee at the American Academy of Orthopedic Surgeons. Over 1,000 patients who were implanted with the Zimmer NexGen system between 2000 and 2011 participated in the study. Overall complications were present in 3.9 percent, with 50 percent of those involving premature loosening. Researchers discovered that the majority of the loosening-related failures were caused by the tibial component separating from the bone.

An estimated 150,000 Zimmer NexGen devices have been sold worldwide.