Stryker Corp. (NYSE:SYK) resolved all outstanding issues related to a warning letter the company received from the Food & Drug Administration in 2007, which led to a recall of some of its Trident hip implants.
The original warning letter, dated November 28, 2007, was filed after FDA inspectors examined the company’s Mahwah, N.J., manufacturing facility and determined that quality gaps had contributed to faulty hip implants. It was one of two warning letters the company received from regulators in 2007 over failures in its quality systems.
In the hip implant warning letter, FDA officials chastised Stryker for repeatedly failing to perform corrective procedures despite several reports of problems with the implants.
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“In some instances these problems have required revision surgeries. In addition, complaints were also received between January of 2005 through April of 2007 for squeaking noises of hip implants with ceramic bearing components; some of those problems resulted in revision surgeries due to implant failures (fractures, pain, wear particles, and fragments),” according to the letter. “Furthermore, complaints were received between January of 2005 through June of 2007 concerning improper seating of hip implants in broached bones resulting in bone fractures.”
Inspectors said that bacterial contamination in the plant, including reports of Staphylococcus, a bacteria that causes staph infections, were contributing to the problems with the implants.
Company officials have said the problems uncovered in the 2007 warning letters, as well as an additional warning it received over its Hopkinton, Mass.-facility in 2008, led to a renewed focus by the Kalamazoo, Mich.-based company on quality assurance systems.
In September 2009 the company named Lonny Carpenter to the newly created position of group president for global quality and operations, after spending more than $50 million in 2008 on the initiatives and an estimated $75 million in 2009. The company pledged a total of $200 million over three years to clean up its quality systems.
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Tuesday’s announcement was hailed by CEO Stephen MacMillan as a step forward.
“The resolution of the Mahwah, New Jersey Warning Letter is another important step in demonstrating our firm commitment to significantly transforming our quality systems throughout our organization,” MacMillan said in prepared remarks. “The investments we have made, and will continue to make, are resulting in solid progress toward our goals.”
The Massachusetts Medical Devices Journal is the online journal of the medical devices industry in the Commonwealth and New England, providing day-to-day coverage of the devices that save lives, the people behind them, and the burgeoning trends and developments within the industry.
