Federal health officials warned last month that a plant where Zimmer Trilogy hip replacements are manufactured was out of compliance.
In a report filed with the Security Exchange Commission (SEC) on October 1, Zimmer Holdings, Inc. announced that it received a warning letter from the FDA on September 19, concerning its manufacturing facility in Ponce, Puerto Rico, where the company makes it’s Trilogy Acetabular System, a metal and polyethylene hip replacement system.
According to the information disclosed by Zimmer, the FDA warned the company about problems at the Trilogy hip plant involving failure to implement a testing mechanism to demonstrate that the components meet design specifications. The plant has also failed to validate certain manufacturing operations that involve the use of metallic spikes.
Zimmer reports in its filing that it temporarily suspended release of the affected products while addressing the FDA’s concerns. The company claims that it has provided detailed responses to the FDA’s concerns and will not have to perform a Trilogy Acetabular System recall. The letter also does not affect the company’s ability to seek FDA fast-track approval for products.
The company says it has already validated and resumed manufacturing of the Trilogy components that do not involve the metallic spikes. However, the report warns that the company cannot guarantee that the FDA will be satisfied with the company’s solutions to the Trilogy hip manufacturing problems outlined in the warning letter and that the company could be subject to additional regulatory actions.