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 The product is not being withdrawn from the market.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).