Zimmer’s hip replacement manufacturing troubles are the focus of a September 19, 2012 FDA warning to the beleaguered company.
The FDA cited Zimmer’s Trilogy Acetabular System hip replacement devices manufacturing process and testing at a Ponce, Puerto Rico facility. The FDA warning letter followed FDA inspection of the plant in June.
Lack Of Testing
Evidently the problem stemmed from a lack of testing, as FDA inspectors were troubled that Zimmer had no testing mechanism to show that Trilogy products matched pre-determined design specifications. Additionally, the FDA noted the absence of quality test manufacturing at the Puerto Rico plant of Trilogy products “that incorporate metallic spikes.”
The warning letter did not restrict production or shipment of the hip devices or require withdrawal of any products from the market, Zimmer said in the filing.
However, Zimmer responded to the issues by saying it has since notified customers of the manufacturing issues, and temporarily stopped producing affected products at the plant after receiving the warning letter. It has now resumed producing Trilogy products that lack metallic spikes, and claims its manufacturing processes in this area now meeting FDA specifications. Separately, Zimmer said it will finish the manufacturing validation process for Trilogy products with the metal spikes within the next few weeks. But, the FDA must then still sign off on the measure.
The Trilogy hip includes a number of components, starting with a base fiber metal. Patients can subsequently choose a bearing made of polyethylene, metal or ceramic, according to Zimmer’s web promotional materials.
Zimmer also makes a highly controversial metal on metal implant. And their all-metal hip replacements are among many manufactured by a number of different companies that have been receiving negative attention because of safety concerns. The FDA, for example, is asking 20 device makers, including Zimmer, to explore whether its implants affect patients with dangerously high levels of metal in the blood.[hr]