FDA Warning Letter for Zimmer Trilogy Hip Implant Facility

October 3, 2012 — Zimmer Holdings Inc. disclosed that they have received a warning letter from the U.S. Food and Drug Administration (FDA) regarding problems at a Puerto Rican facility that manufactures and tests hip implants. The facility, located in Ponce, manufactures the Trilogy Acetabular Systems, which consists of a metal “cup” and a plastic liner that are implanted in a patient’s hip socket.

According to the FDA warning letter, dated September 19, Zimmer failed to implement a testing mechanism to show the products meet design specifications. The company also failed to complete a validation process for Trilogy products that incorporate metal spikes.

FDA investigators visited the Puerto Rican facility in June. The warning does not require Zimmer to stop manufacturing or selling the product, nor is it being withdrawn from the market. However, Zimmer has voluntarily halted sales of the affected products until the company completes the validation process.

Zimmer faced a major product liability crisis that began in 2010, researchers found the Zimmer NexGen knee replacement had a high rate of failure. The company subsequently issued several recalls of the device, which can loosen prematurely, cause pain, bone loss, and may require revision surgery.

This is also the second major warning letter from the FDA to target medical device companies that manufacture their products in countries outside the U.S. In August, the FDA sent a warning letter to Hospira Inc. regarding problems at a Costa Rican facility that manufactured infusion pumps. The FDA found that Hospira failed to adequately address known problems with the device’s alarm system.

The FDA has not yet posted the official warning letter publicly. Zimmer disclosed that they received the letter in a regulatory filing with the Securities and Exchange Commission (SEC) and shareholders.