FDA Sends Warning Letter Regarding Zimmer Trilogy Hip System
In September 2012, the FDA sent a warning letter to Zimmer Holdings, Inc. regarding the company’s manufacturing facility located in Ponce, Puerto Rico. The FDA informed the manufacturer that it had failed to meet required testing of its Trilogy hip implant. Although the company claims to have rectified some of these issues and to be working on the others, similar concerns with other implants have led to Zimmer hip replacement lawsuit complaints.
Anyone who has been injured after receiving a Trilogy or other hip device should contact a Zimmer hip lawyer to discuss the requirements and qualifications of a Zimmer hip lawsuit.
FDA sends warning letter to Zimmer Holdings
On October 1, 2012, Zimmer Holdings, Inc. filed a report with the Security Exchange Commission (SEC). The report detailed a September 19, 2012 warning letter from the FDA warning Zimmer that its Ponce, Puerto Rico manufacturing facility was out of compliance. The Ponce facility is where the company manufactures its Trilogy Acetabular hip system, a hip replacement that contains both metal and polyethylene components.
It is possible that the FDA warning will be cited in Zimmer hip replacement lawsuit complaints, some of which allege that the Trilogy implant is defective.
Zimmer facility fails to implement proper testing
According to Zimmer’s report to the SEC, the FDA informed the manufacture that the Trinity hip plant had failed to implement a mechanism to test whether the device components met design specifications. Additionally, the FDA warned Zimmer that the Puerto Rico plant had not been able to validate certain manufacturing operations that incorporated components featuring metallic spikes.
Zimmer plans to rectify plant concerns
In response, Zimmer indicated that it would notify customers of the disclosed issues. While Zimmer corrects the FDA’s cited concerns, it indicated that it would temporarily suspend all affected device components. However, the company also noted that the FDA warning did not require, nor would the company complete, any withdrawal or recall of the Trilogy hip replacement.
Zimmer indicated that it has already validated Trilogy components that do not have metallic spikes, and that it expected to complete within weeks the validation of the Trilogy spiked shell products. Additionally, the manufacturer stated that it would seek the FDA-fast track approval for its products.
Recipients of the Trilogy hip system who have experienced implant failure have contacted a Zimmer hip lawyer to see if they are eligible for litigation.