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| Keefe
Bartels & Clark LLC
Attorneys At Law
Toll
Free: 877-288-9247
Monmouth County Office
170 Monmouth Street
Red Bank NJ 07701
tel: 732.224.9400
fax: 732.224.9494
Newark
Office
56 Ferry Street
Newark, NJ 07105
tel: 973.274.0408
fax: 973.274.0409
Middlesex
County Office
25 South Main Street, Suite 8
PO Box 6386
Edison, NJ 08818
tel: 732.391.4708 |
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Zimmer
Durom Hip Cup Replacement Problems
Founded
in 1927 and headquartered in Warsaw, Indiana, Zimmer claims to be
a worldwide leader in designing, developing, manufacturing and marketing
orthopaedic reconstructive trauma devices, including total hip replacements.
Total hip arthroplasty (THA), or total hip replacement, is a medical
procedure performed on more than 442,000 patients in the U.S. each
year. Zimmer owns a quarter of the total hip market, making it the
world leader.
In the U.S., Zimmer’s Durom Cup (also known as the "Durom
Acetabular Component" or "Metasul Durom") was cleared
for marketing in THA by the FDA in mid-2006. The Durom Cup has been
implanted in approximately 13,000 patients since it was first sold
in the United States. The Durom Cup was designed for use in younger
patients who are likely to outlive a conventional hip prosthesis.
However, the results for many patients has been just the opposite,
as the metal component of the hip implant fails to bond properly
with the existing bone. Instead, the metal socket loosens and separates,
resulting in severe pain and ultimately device failure, necessitating
an expensive and painful revision surgery for patients.
The problems with the Durom Cup first came to light in 2007 when
prominent orthopedic surgeon Dr. Lawrence Dorr, the Director of
the Dorr Institute for Arthritis Research and Education, alerted
Zimmer that Durom Hip Implant had an abnormally high failure rate.
The company did nothing, forcing Dr. Dorr to take the issue public.
In April of 2008, Dr. Lawrence Dorr publicly warned other orthopedists
about failures with the Zimmer Durom Cup his patients had experienced.
His letter to fellow doctors reads in relevant part,
“This
NOTICE is to inform you that we have had ten revisions in 165
hips and have four more that need to be revised using the Durom
cup.
This failure rate has occurred within the first two years. In
the first year the x-rays looked perfect. We have revised four
that did not have any radiolucent lines or migration (and John
Moreland revised one). These early cups fooled us, but the symptoms
were so classic for a loose implant that we operated the patients.
When we hit on the edge of the cup it would just pop free. As
time goes by the cups begin developing radiolucent lines. We
now have one cup at two years that has actually migrated a short
distance. It has tilted into varus. We do not believe the fixation
surface is good on these cups. Also there is a circular cutting
surface on the periphery of the cup that we believe prevents
the cup from fully seating. We stopped using the cup after the
first revisions.
We have notified Zimmer. The FDA has been notified and we will
notify them of our continued revisions. The company does not
believe it should pull the cup from the market so I am notifying
all of my colleagues of our failure rate with this cup. I went
through a similar scenario with the Sulzer cup failures where
I was the only one experiencing revisions at the beginning and
basically it was assumed that it was our technique. I can assure
you that this goes beyond technique. I learned my lesson in
not informing everyone about this magnitude of failures with
the Sulzer cup problem, so it is my obligation to do so with
this cup.”
In May of 2008, Zimmer finally announced it would begin an investigation,
but made no indication it would recall the device or halt sales.
Then on July 24th, 2008, Zimmer suspended the marketing and distribution
of the Durom Cup in the United States. [READ
the Notice here] It didn’t suspend marketing outside
the U.S., where lower revision rates had been reported. Zimmer declared
their investigation had revealed that the Durom Cup was not defective.
Rather, the company blamed the doctors. It stated that surgeons
had found the device difficult to implant, and that it was the responsibility
of doctors to receive more training on how to implant the device.
Zimmer then updated the device label and implemented a surgical-training
program in the U.S.
Since that time, hundreds of patients have suffered device complications
and failures due to the Zimmer Durom Hip Cup. If you or a loved
one had a Zimmer Hip Replacement between 2006 and 2008 and believe
it might have been a Durom Cup, please contact us immediately to
protect your rights.
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