Doctor Brings to Attention Problems With Zimmer Durom Cup Hip Replacement Devices
A story about a local doctor and his patient’s problems brought about by the Zimmer Durom cup medical device can be found in a June 8, 2009 article in the Fort Wayne Journal Gazette. When Dr. Lawrence Dorr noticed patients had problems with the Durom cup, a hip-socket implant, loosening last year, he didn’t wait to act. He felt a moral obligation, he said, especially considering what he’d been through about a decade before.
At the time, Dorr approached Sulzer Orthopedics about problems with a cup it made. The Austin, Texas, subsidiary of Swiss company Sulzer Medica later became Centerpulse, now owned by Zimmer. Sulzer Orthopedics at first blamed surgeon technique, but Dorr told fellow surgeons about his concerns at meetings. Looking back, Dorr thinks he should have done more.
In December 2000, Sulzer recalled thousands of the cups after it was revealed a manufacturing change had contaminated some with an oily residue preventing the new joint from bonding with patients’ bones. The company reached a $750 million settlement with U.S. patients who received the faulty joints to end a class-action case. Up to 4,000 people had to undergo a second operation, The Associated Press reported.
That stuck in Dorr’s mind. In the spring of 2008, Dorr approached Zimmer about problems some of his patients were having with the Durom cup. When the device manufacturer told him it saw no reason to pull the cup, he decided to go public.
He sent a letter in April 2008 to members of the Hip Society and American Association of Hip and Knee Surgeons, where he was past president. In July 2008, Zimmer announced it was suspending the marketing and distribution of a hip product in the U.S. after problems were reported by a group of surgeons.
Not everything aligns with the Sulzer scenario. In this case, Zimmer continues to publicly stand behind the Durom cup. Although U.S. distribution and marketing were temporarily halted in July, the implant was back on the market the next month.
Of surgical sites it investigated in the U.S., Zimmer said those using the techniques it prescribes had a 1.5% revision surgery rate. The revision rate for other sites is 5.7%, according to a July 2008 surgeon notification Zimmer posted on its Web site.
Dorr continues to use other Zimmer products but stands by his assertion that a product flaw is to blame for revision issues. Zimmer is equally adamant that isn’t the case.
Peper Long, a spokeswoman with the FDA, said the product was proved safe and effective compared with similar devices on the market when it was first cleared for use. But, she said, the product recall isn’t over.
The Durom cup is on the market. The recall refers to changes in product labeling Zimmer made to improve its safety.
The FDA’s Center for Devices and Radiological Health, which reviews medical devices, “will continue to monitor adverse event reports for this device,” Long said.
