--Zimmer says FDA inspection of Puerto Rico plant turned up
concerns about manufacturing of certain implants
--FDA in letter noted manufacturing, testing issues related to
Trilogy Acetabuar System products, company says
--Zimmer says it is notifying customers of manufacturing issue,
but hasn't withdrawn any products
(Adds context on metallic spikes in fourth paragraph and a no
comment from Zimmer in seventh paragraph.)
By Kristin Jones
Zimmer Holdings Inc. (ZMH) said a U.S. Food and Drug
Administration inspection of its plant in Puerto Rico turned up
concerns about the manufacturing of certain hip implants.
The orthopedic maker's Zimmer Inc. subsidiary received a warning
letter from the FDA dated Sept. 19, the company said in a
regulatory filing Monday. In the letter, the FDA noted
manufacturing and testing issues related to the company's Trilogy
Acetabular System products, which are implanted in hip-replacement
surgery.
Specifically, the U.S. drug regulator noted that Zimmer hadn't
implemented a testing mechanism to show that its products met
design specifications. The company also hadn't validated the effect
of certain manufacturing operations on Trilogy products that
incorporate metallic spikes.
Spikes are used to connect the hip replacement cup to a
patient's bone when cement and screws are deemed insufficient.
The FDA requires that drug and medical-device makers undertake
steps to ensure the quality of the design and manufacture of its
products, known as process validation.
Zimmer said it is notifying customers of the manufacturing
issue, but that it hasn't withdrawn any products. The company also
said it previously suspended release of the spiked products,
pending validation of the processes cited in the letter, and
expects to complete validation in the next few weeks.
A Zimmer spokesman declined to comment further.
Shares gained 11 cents to $67.98 in after-hours trading. Through
Monday's close, the stock was up 27% so far this year.
--Joseph Walker contributed to this article.
Write to Kristin Jones at kristin.jones@dowjones.com
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