A Medical Device Daily
Artificial hip and knee maker Stryker (Kalamazoo, Michigan) finds itself in more hot water as the FDA has issued it a warning letter concerning its Trident hip-replacement systems.
The FDA letter cited complaints from January 2005 to April 2007 “for squeaking noises of hip implants with ceramic-bearing components.” Some problems resulted in additional surgeries for implant failures such as fractures and pain, the letter said.
The letter was posted on the FDA website Tuesday and lists infractions at Stryker’s Mahwah, New Jersey, plant, including failure to fix quality problems related to its Trident hip-replacement systems. The 11-page letter was dated Nov. 28.
Stryker in a statement said it has been working with the FDA to resolve the issues since July 2007, but did not comment on the specifics of the FDA complaints.
The company’s hip, knee and shoulder implants are a major revenue generator, with worldwide sales of $2.6 billion for the first nine months of 2007, according to the company’s most recent financial report.
The FDA sent Stryker a warning about a plant in Ireland last March, citing the company’s failure to remedy quality problems there (Medical Device Daily June 20, 2007).
More than half of the company’s reconstructive products are made at the New Jersey and Ireland plants, according to BMO Capital Markets.
“In the least, we doubt products will be approved by the FDA until the warning letters are resolved. But, at this stage, it does not appear to be a significant issue for the company, nor an obstacle in delivering numbers,” BMO analyst Joanne Wuensch wrote in an investor note.
Just last month a federal court judge in Portland, Oregon issued a permanent injunction against the company prohibiting it from further sales of its T2 Proximal Humeral Nail used in the treatment of shoulder fractures (MDD, Dec. 14, 2007).
In September 2005, a jury found that Stryker’s product infringed a patent covering a device to treat shoulder fractures held by much smaller orthopedic developer Acumed (Hillsboro, Oregon) (MDD, Sept. 23, 2005).
Stryker appealed that ruling, and in June 2007, the U.S. Court of Appeals for the Ninth Circuit affirmed the jury’s verdict of willful infringement, and remanded the case for a determination by Judge Anna Brown of the U.S. District Court for the District of Oregon as to whether a permanent injunction should be issued.
Stryker shares closed down $1.35, or 1.86%, at $71.11 on the New York Stock Exchange. The shares had been down less than 1% before news of the letter was reported.