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FDA Warning Letter for Zimmer Trilogy Hip Implant Facility


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FDA Warning Letter for Zimmer Trilogy Hip Implant Facility

Please note: The Schmidt Firm, PLLC, is no longer accepting Trilogy hip implant claims. If you feel that you may have a potential case, we urge you to locate another law firm adequately suited to handle your claim.

October 3, 2012 — The medical device company Zimmer Holdings Inc. disclosed in a regulatory filing that the U.S. Food and Drug Administration (FDA) sent them a warning letter regarding manufacturing and testing deficiencies at a facility in Puerto Rico. The facility is located in Ponce, and is responsible for making the Trilogy Acetabular Systems. The device is implanted in a patient’s hip socket, and consists of a metal “cup” with a plastic liner.

The warning letter, dated September 19, alleges that Zimmer failed to conduct a validation process for Trilogy hip implants that incorporate metal spikes. The FDA also found that Zimmer failed to show that the implants met design specifications by implementing a testing procedure.

The citations stem from an inspection the FDA conducted in June. The warning letter does not ask Zimmer to stop making the hip implants. The product is not being withdrawn from the market. Zimmer has voluntarily stopped distributing the Trilogy implants until they can complete the validation process.

Zimmer has previously faced product liability lawsuits stemming from their line of NexGen knee implants. In 2010, researchers found a high rate of failure and loosening of the device. Zimmer issued several recalls.

The FDA also recently sent Hospira a warning letter about deficiencies at a Costa Rican manufacturing facility. The facility failed to address known issues with the alarm system on the company’s infusion pumps.

The contents of the warning letter have not been posted publicly by the FDA. It was disclosed to shareholders in a mandatory regulatory filing with the Securities and Exchange Commission (SEC).

Do I have a Zimmer Trilogy Lawsuit?

The Schmidt Firm, PLLC is currently accepting Zimmer Trilogy induced injury cases in all 50 states. If you or somebody you know has been injured by a Zimmer Trilogy hip implant, you should contact our lawyers immediately for a free case consultation. Please use the form below to contact our Defective Medical Device Litigation Group or call toll free 24 hours a day at (866) 920-0753.

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