Zimmer Biomet/FDA Squabble
Another disruptive story for one company continued to capture our reader’s attention—Zimmer Biomet’s ongoing regulatory problems and subsequent inventory disruption at the former Biomet North Campus plant in Warsaw, Indiana, following a 2016 FDA inspection.
The disruption impacted sales and earnings, resulting in the ouster of the company’s CEO Dave Dvorak.
In 2018, the company and agency traded public barbs over follow up inspections and a new Warning Letter in which the FDA demanded a meeting. The next inspection is scheduled to take place sometime in the Spring of 2019.
The Surgeons
Readers continued to show strong interest in stories about surgeon accomplishments, as well as learning from the mistakes of those behaving badly.
Richard Rothman Legacy
At the top of the accomplishment list was the celebration of the founder of the Rothman Orthopaedic Institute in Philadelphia, Richard Rothman, M.D., after his passing in October.
Alex Vaccaro, M.D., now the President the Institute, said of his dear friend, “Dick cared deeply about others’ well-being … and ‘held’ each person with his eyes, offering them his presence. He was devoted to his employees and spent time at the end of each day walking around and chatting with people in different departments.”
Born in nearby Cheltenham, Pennsylvania, he pursued his love of history at the University of Pennsylvania, then obtained a Ph.D. in anatomy from Thomas Jefferson University in Philadelphia. After earning an M.D. from the Perelman School of Medicine at the University of Pennsylvania in 1962, Rothman returned to Jefferson for a residency.
Seven years after graduating from medical school, he went to England and learned how to perform hip replacement surgery from John Charnley. Charnley was so impressed with Rothman that when Walter Annenberg sought out Charnley for hip surgery, Charnley sent him to Rothman. Annenberg was grateful and provided millions to the Rothman Institute.
Rothman would eventually perform more than 50,000 hip and knee procedures and after retirement worked with companies in developing newer and better procedures. He was instrumental in the development of the Accolade total hip system (now made by Stryker Corporation), which has become one of the most prominent and widely used hip systems in the United States, Australia, Canada, and Asia. The Stryker Accolade has been used in over 200,000 patients to date.
He was also active in the development improvement of highly cross-linked polyethylene bearings including Crossfire and X3, as well as the continued development of the Trident shell.
“It’s like a cliché,” said Vaccaro, “but he was truly larger than life, always smiling and full of interesting stories. He drove himself forward with curiosity, had an entertaining persona, and was deeply insightful and calm.”
