Zimmer ($ZMH) is in trouble with the FDA over manufacturing shortfalls involving a hip replacement device.
Regulators slapped the Indiana devicemaker with a warning letter regarding its Trilogy Acetabular System devices, citing problems over how product is manufactured and tested at a Ponce, Puerto Rico facility, the company disclosed in a recent regulatory filing. The Sept. 19, 2012 warning letter follows regulator inspection of the plant in June.
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."
Zimmer smartly responds to the issues in its regulatory filing. The company says 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. (The FDA must 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.
Separately, Zimmer's all-metal hip replacements are among many manufactured by a number of different companies that have drawn regulatory 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.
- here's the regulatory filing
- check out Reuters' take