Zimmer NexGen Knee Recall Issued For MIS Tibial Components

A number of parts used in the Zimmer NexGen Complete Knee Solution MIS procedure were quietly recalled last year after numerous reports of failure. 

On September 13, 2010, a Zimmer NexGen knee recall was issued for NexGen TM Tibial Trays, NexGen MIS Tibial Components and MIS Modular Tibial Plates and Keels, according to information in an FDA medical device recall database.

The recall went widely unreported, without any apparent FDA alert or press release issued by Zimmer. Information about the recall on the FDA’s website was just updated on March 28, 2011.

Did You Know?

AT&T Data Breach Impacts Millions of Customers

More than 73 million customers of AT&T may have had their names, addresses, phone numbers, Social Security numbers and other information released on the dark web due to a massive AT&T data breach. Lawsuits are being pursued to obtain financial compensation.

At least 114 reports of Zimmer NexGen knee problems have been associated with the recalled components, according to information posted by the FDA in connection to the recall. Problems included reports that the Zimmer NexGen knees had loosened and that patients had to undergo additional knee surgery to have the devices replaced.

The FDA also indicates that on April 26, 2010, Zimmer sent a letter to healthcare facilities and customers who had bought the device to destroy or disregard all previous guides on the surgical techniques needed to install the implants and sent out revised surgical guides.

The Zimmer NexGen recall affected 68,384 knee components, which were distributed in 13 states across the U.S.

A number of Zimmer NexGen knee replacement lawsuits have been filed on behalf of individuals who have received devices manufactured by the company, most involving the Zimmer NexGen CR-Flex knee, which does not appear to be involved in this Zimmer knee recall.

Last year, concerns about problems with the Zimmer NexGen CR-Flex knee were raised by Dr. Richard A Berger, a former consultant for the manufacturer. Dr. Berger complained that the adhesive-free version of the Zimmer knee implant was not fusing to patients’ bones as it should.

Zimmer dismissed Dr. Berger’s concerns, canceled their relationship with the orthopaedic surgeon and claimed that the problem lay in his surgical skills. This came after the company reportedly paid Dr. Berger $8 million over a 10 year period to work as an orthopedic consultant.

Dr. Berger and another surgeon presented a study at the American Academy of Orthopaedic Surgeons annual conference in New Orleans in March 2010, which suggested that the Zimmer NexGen CR-Flex knee replacement problems resulted in nearly a 10% failure rate.

1 Comments

  • JeffreyApril 3, 2011 at 7:44 am

    Total knee Recall

Share Your Comments

I authorize the above comments be posted on this page*

Want your comments reviewed by a lawyer?

To have an attorney review your comments and contact you about a potential case, provide your contact information below. This will not be published.

NOTE: Providing information for review by an attorney does not form an attorney-client relationship.

This field is for validation purposes and should be left unchanged.

More Top Stories

Uber Driver Sexual Assaults and Misconduct Reports Must Be Disclosed in Lawsuit Discovery
Uber Driver Sexual Assaults and Misconduct Reports Must Be Disclosed in Lawsuit Discovery (Posted today)

A federal magistrate judge is forcing Uber to hand over potentially hundreds of thousands of incident files involving reports of passengers who suffered sexual misconduct or sexual assault at the hands of the rideshare service's drivers.

Abbott May Remove Infant Formula for Preemies Off the Market Due to Similac NEC Lawsuits
Abbott May Remove Infant Formula for Preemies Off the Market Due to Similac NEC Lawsuits (Posted yesterday)

Abbott Laboratories is considering removing Similac infant formula products designed for preterm babies from the market, as it faces hundreds of lawsuits claiming the products increase the risk of necrotizing enterocolitis, which puts newborns at a high risk of permanent injuries and death.

Information About Suboxone Dental Claims To Be Exchanged By Parties in MDL
Information About Suboxone Dental Claims To Be Exchanged By Parties in MDL (Posted 2 days ago)

A federal judge has ordered parties involved in Suboxone dental decay lawsuits to submit proposals for exchanging information that will guide the selection of representative bellwether claims for early test trials.