Durom Cup
If you're one of the thousands of U.S. patients
who've had a hip replacement in recent years, take note:
a major problem has surfaced with a medical product used
in those operations -- and you may need another surgery
to correct it.
The product is the Durom Cup, a metal hip socket that
is used to replace worn-out hip joints. Sold in the
United States since 2006, the Durom Cup has been
implanted in about 13,000 patients worldwide --
including 1,300 hip replacement patients in the U.S.
Concerns about the device came to light in April 2008
when Dr. Lawrence Dorr, a prominent California surgeon,
publicly warned other orthopedists about Durom Cup
failures among his patients. Dr. Dorr is the founder and
medical director of the Dorr Institute for Arthritis
Research and Education. He has performed more than 3,500
hip and knee replacements in the past decade.
In a letter to the American Association of Hip and
Knee Surgeons, Dr. Dorr said he had to perform 10
revisions with the Durom Cup in a total of 165 hips that
he fitted. The cups failed within the first two years,
he said.
"The symptoms were so classic for a loose implant
that we operated the patients," Dr. Dorr wrote. "When we
hit on the edge of the cup it would just pop free."
Dr. Dorr said he was going public with his concerns
about the cup's failure because "the company does not
believe it should pull the cup from the market."
The manufacturer of the Durom Cup, Zimmer Holdings,
Inc., was slow to respond. Finally, on July 22, 2008,
Zimmer announced it was voluntarily suspending U.S sales
of the product and advised surgeons here to stop
implanting them.
Even so, the company said the problem was with the
surgical technique when the device was implanted, not
the product itself. “The company is taking the necessary
steps to address the apparent surgical training need, so
that patients in the U.S. can consistently experience
the results for which the Durom Cup was developed,” said
Zimmer President David C. Dvorak.
Dr. Dorr disputed that conclusion. He pointed to a
product defect as the likely culprit. "I can assure you
that this goes beyond technique," he said, noting some
of the cups actually migrated a short distance. "There
is a circular cutting surface on the periphery of the
cup that we believe prevents the cup from fully
seating."
Some doctors fear the number of patients who will
need to have their Durom Cups replaced could be in the
hundreds.
The problem has attracted national media attention,
including an
article in the New York Times.
If you had a hip replacement where the Durom Cup was
implanted, you may have a defective medical device, and
you need to move quickly to protect your legal rights.
Contact us by telephone at 816-531-4440.
There is no charge to you for the telephone
consultation. We work on a contingent fee basis. We only
get paid if you recover compensation.
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