Zimmer receiver FDA warning over manufacturing, testing processes at Puerto Rico facility

Medical device maker Zimmer Holdings Inc. has received a federal regulatory warning over invalid manufacturing and testing procedures being conducted on one of its hip implants. The company is currently engaged in ongoing legal battles over its allegedly defective line of NexGen knee implants.

According to a Reuters report this week, Zimmer notified shareholders of the warning via a quarterly report filed with the Securities and Exchange Commission. The warning from the Food and Drug Administration indicates that Zimmer “failed to implement a testing mechanism to demonstrate (Trilogy Acetabular Systems) met certain design specifications and had not validated the effects of manufacturing operations on products that incorporate metallic spikes.”

The Trilogy devices are manufactured at the company’s Ponce, Puerto Rico, facility. In response, Zimmer said it has suspended the release of these products and in the interim has completed the processes required by the FDA on its products that do not use metallic spikes. The company said it will complete testing and validation processes on products that do incorporate metallic spikes in the “next few weeks.”

The FDA is not requiring Zimmer to withdraw any products from the market in making this warning, though the company said it was halting the release of these specific devices. The regulatory action comes just a few months following an inspection of that Puerto Rico facility in which the FDA noted the flaws in Zimmer’s processes.

This is the latest bad news for Zimmer, especially concerning its line of artificial joints. Currently, the company is facing numerous lawsuits filed by recipients of the company’s NexGen line of knee implants. Across the country, recipients of these devices (including the

This entry was posted in Defective Medical Devices, NexGen LPS femoral component, Zimmer NexGen CR-Flex knee implants, Zimmer NexGen LPS femoral component, Zimmer NexGen MIS Tibial Components and tagged . Bookmark the permalink.


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