Is there a Zimmer knee replacement recall?
A Zimmer knee replacement recall has only occurred in two very specific instances. On Sept. 13 2010, the Food and Drug Administration (FDA) recalled certain NexGen Complete Knee Solution MIS Tibial Components and on Dec. 2, 2010, it recalled specific Zimmer NexGen Complete Knee Solution LPS Femoral Components. NexGen knee replacements remain on the market and are in wide use today.
History of prior recalls
In September 2010, problems with certain NexGen MIS parts including TM Tibial Trays and MIS Modular Tibial Plates and Keels resulted in a voluntary recall after thousands of products were distributed.
Later in 2010, the company announced a much more limited recall of certain LPS Femoral Components and removed several sizes of femoral components form the market. The stated reason for the recall was “nonconforming geometry.” The FDA announced the recall in December of that year.
Eachrecall fell within an FDA Class 2 recall. Class 2 recalls are issued when a product “may cause temporary or medically reversible adverse health consequences or when the probability of serious adverse health consequences is remote.”
Zimmer NexGen Knee replacements remain in wide use
Neither Zimmer knee recall prompted the device manufacturer to remove any other model from the market. However, the company’s high-flex devices have received some negative attention in recent years.
In 2010, Dr. Richard Berger, a former Zimmer consultant and orthopedic surgeon, along with a colleague presented their observations in a non-peer reviewed report entitled “The High Failure Rate of a High-Flex Total Knee Arthroplasty.” The report summarized the doctors observations of 108 patients, 36% of whom showed signs of “radiographic loosening.” Approximately 8% of those patients had knee revision surgery within just a few years of having their initial implant surgery. Though Dr. Berger’s report recommended that the “device not be used on any patient,” the CR-Flex remains in use today.
Zimmer stands by its NexGen products
There is no indication that Zimmer will ever issue a voluntary recall of its high-flex models. The device manufacturer strongly contests the allegations it faces and stands firmly behind its product. Zimmer blames the surgeons for poor technique and uses international registry statistics in support of the implants’ efficacy and safety record.
Today, the company faces lawsuits, many consolidated in Zimmer knee multidistrict litigation, with regard to NexGen replacement components including the LPS-Flex, the CR-Flex, GSF LPS-Flex, GSF CR-Flex, and MIS Tibial components.