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It’s been more than two years since Trudie Millerburg had hip replacement surgery, and she is still putting the pieces back together.
Millerburg, 63, a retired clinical lab scientist, can’t stoop to dust the bottom of her cabinets. She can’t bend over to clear bugs off her car or garden.
Once independent and active to the core, Millerburg now hires others to do certain tasks for her for fear of dislocating her hip. She’s lost sleep to pain, and her inability to move easily has been upsetting for a woman who loves to hike the Sierra Nevada mountain range near her home in Big Pine, Calif.
“I’ve fought depression a lot,” Millerburg said.
The pain she feels is no longer constant, the depression has lifted, and she’s gotten back her zest for living. But she has another surgery to endure – one she hopes will be a permanent fix to a lingering problem. And she wants to regain her old life.
When Millerburg had total hip replacement in April 2007, she had a Durom cup made by Warsaw-based Zimmer Inc. implanted in her right hip.
The metal implant looks roughly like a small hollowed and halved sphere into which another round metal component is inserted, simulating the head of a femur.
After the operation, the implant was supposed to fuse with bone. Instead, it loosened, rubbing against nerves in Millerburg’s hip, causing considerable pain and requiring more surgery. Others had similar problems.
In July last year, Zimmer temporarily suspended the marketing and distribution of the product domestically after some U.S. surgeons reported higher-than-normal revision surgery rates using the Durom cup.
Zimmer updated labeling to provide more detailed surgical-technique instructions and implemented surgical-training programs in the U.S. It didn’t suspend marketing outside the U.S. where lower revision rates were reported.
The orthopedic-device maker has since poured tens of millions of dollars into settlements, setting aside money for future lawsuits. And its hip business – still the largest in the world – has taken a hit.
A suit filed in April in St. Clair County, Ill., on behalf of 43 people, said the company was liable for its “defective and dangerous product” and accused Zimmer of concealing the product’s defectiveness. It alleged the implant caused injury and financial problems for plaintiffs from more than 25 states, including Indiana.
An attorney for the plaintiffs, John J. Driscoll of St. Louis, said the proceedings are in the preliminary stages. Last week, Driscoll said he was still awaiting Zimmer’s response. He expected at least two more plaintiffs would be added.
A Zimmer spokesman declined to comment on the suit. The company has maintained that problems associated with the Durom cup were related to training, not a product flaw. Zimmer has said the product is safe and effective.
But Millerburg’s surgeon, who alerted colleagues last year to problems associated with the implant, thinks otherwise. Dr. Lawrence Dorr, who has done consulting for Zimmer and still uses other company products, no longer uses the Durom cup.
“We had failures with it, and we didn’t think it was a good design,” said Dorr, founder of the California-based Dorr Institute for Arthritis Research and Education Foundation. He thinks the design of the cup, which flairs out compared with a traditional hemispheric shape, can prevent bone in-growth integral to a long-term fix.
More recently, Dorr said he reviewed changes Zimmer made to the implant and would use the modified version of the cup if it gets approved for market. Dorr said the modified cup is more hemispheric and conventional in design, and he expects it to be phased in.
Zimmer spokesman Brad Bishop denied the product Dorr reviewed is a modified version of the Durom cup. Rather, he said in an e-mail that Zimmer is developing another metal-on-metal cup for hip replacement that it’s planning to launch the second half of this year.
“This is a new design that is an addition to our product portfolio and is not an updated version of the Durom product,” Bishop said in the e-mail.
Whatever the case, Dorr isn’t the only surgeon who has stopped using the Durom cup.
A local surgeon knew of the cup being implanted just three times in the area since the FDA approved it in 2006.
Dr. Jeff Harris of Orthopaedics Northeast implanted the Durom cup once and, though the surgery went well, he doesn’t plan to use it again. He doesn’t expect other area surgeons to implant it either, although he heard from a Zimmer sales rep that the two other area operations involving the cup also went well.
“It wasn’t a popular thing,” said Harris, who specializes in hip and knee replacement. And local market dynamics do not favor Zimmer hip implants. Harris and three other surgeons who do a high volume of hip and knee implants in the area don’t generally use Zimmer hip implants, he said.
Not that Zimmer is an unpopular choice for hip implants. The company owns a quarter of the total hip market, making it the world leader. But Zimmer’s market share dropped from 26.2 percent in the first quarter 2008 to 24.7 percent in the first quarter this year, according to figures provided by Scott Ellison, a large-joints analyst with PearlDiver, an orthopedic data firm based in Fort Wayne.
During the same period, Zimmer’s hip revenues fell 9 percent to $300 million compared with $330 million a year ago.
“It’s really hard to pinpoint how much of that was Durom,” Ellison said.
But Zimmer believes that’s been a factor.
In a May governmental filing, the company blamed customer losses on “disruptive factors” last year. Among the factors was the temporary suspension of U.S. marketing and distribution of the Durom cup that began in July and ended in August; a separate temporary production stoppage involving some products at its Orthopaedic Surgical Products plant in Dover, Ohio; and compliance changes related to a 2007 industry settlement.
Customer losses were blamed for an estimated 1.5 percent decrease in Zimmer’s global knee market share, where it’s also a market leader, and a 2 percent decrease in its world hip market share. The company said suspension of Durom cup marketing and distribution contributed to declines in sales.
Zimmer expected share loss to stabilize by year’s end.
For her part, Millerburg doesn’t care whether problems she had with the Durom cup were caused by a product defect or ineffective surgeon training. Either way, she blames Zimmer and has joined a lawsuit against the company.
In January, she had more hip surgery to replace the Durom cup, which had loosened in her right hip.
The more conventional Zimmer implant used in place of the Durom cup didn’t suit the active lifestyle of the tall yoga enthusiast. Her hip dislocated twice, prompting two emergency room visits in April and May to have it forcefully relocated. Millerburg is scheduled for what she hopes will be a more permanent surgical fix in August.
By her estimates, the corrective surgery, ER visits and the upcoming surgery will cost more than $150,000. She expects Zimmer to pay for initial revision surgery and her insurance to cover the ER visits and the next surgery.
This year, Zimmer increased its provision to cover known and anticipated claims associated with Durom cup failures to $69 million. About 12,000 Durom cups had been implanted in the U.S. as of mid-2008, the last time the company provided sales figures. At the time, more than 56,000 had been sold worldwide, and sales continued uninterrupted outside the U.S.
Many people have done well with the implant. Even with the problems Millerburg endured since, “I am happier now (than) before the original total hip replacement,” she said, recalling the constant pain, sleep loss and associated mental and spiritual decline because of the prolonged pain of a hip going out.
“The total hip (replacement surgery) really gave me back my life,” she said.
Millerburg can’t imagine a sedentary lifestyle and still swims and walks regularly despite some pain. But she wants to fully regain her independent lifestyle. She feels limited by her hip brace and hopes the upcoming surgery will finally turn the page on her troubles.
“I’ve lost two years of my life.”
