In a letter from the U.S. Food and Drug Administration (FDA) dated September 19, 2012, Zimmer Holdings Inc. was issued a warning regarding their hip replacement device known as the Trilogy Acetabular System. The letter of warning followed a recent FDA inspection of a Zimmer Holdings Inc. plant located in Puerto Rico.
The FDA observed while at Zimmer’s Puerto Rican plant that the medical device manufacturer had not established proper testing methods for the hip replacement device. The FDA requires that measures for testing be pursued in order to determine if medical devices conform with design mandates and manufacturing requirements.
The FDA letter also noted that Zimmer had neglected to thoroughly inspect and test the impact of manufacturing methods on their Triology hip replacement devices featuring metallic spikes, which are used as anchoring devices in cases where the use of more traditional materials such as screws and cement is unavailable.
Furthermore, the FDA’s warning letter to Zimmer specifically targeted the medical device manufacturer’s inability to provide test data regarding porosity and pore size in their Trilogy Acetabular Cup hip replacements. Zimmer’s design, according to the manufacturer, is intended to promote adherence of the hip replacement device to the adjacent bones without having to use cement, and this adhesion is aided by the porosity and pore size of the hip replacement medical device. However, as the FDA has stated, there is no evidence from testing that these design criteria meet existing standards for porosity and pore size in hip replacement medical devices.
If Zimmer fails to make efforts toward correcting these FDA violations, they could face severe punishment, including regulations, seizure, and fines.
Zimmer has run into complications with another of their hip replacement systems, the defective Durom Acetabular Component, or Durom Cup. The Durom Cup features a metal-on-metal design for use in a total hip replacement surgery. In 2008, Zimmer voluntarily pulled the Durom Cup off of the U.S. market due to increased reports from patients and surgeons about defective acetabular cups, and an elevated need for revision surgery.
The failure rate of Zimmer’s Durom Cup hip replacement devices are abnormally high. If you or someone you love has suffered physical, emotional, and financial losses due to a total hip replacement surgery involving the defective Zimmer Durom Acetabular Component, or Durom Cup, please contact an experienced defective hip implant device lawyer at Carey Danis & Lowe today to discuss your case.References: Defective Medical Device litigation, Hip/Knee Replacement