A
Message from Gary
Sabins, President,
Sulzer Orthopedics:
At Sulzer
Orthopedics, we are
dedicated to
producing the
highest quality hip,
knee and shoulder
implants for the
global healthcare
market. While there
are inherent risks
in providing health
care products,
Sulzer Orthopedics
has a long history
of safe and
effective implants
used in joint
replacement
surgeries by
surgeons and
hospitals around the
world. Our company
takes rigorous
precautionary steps
in the manufacture
of our products.
However, in spite of
best practices, a
failure occurred in
one of our
processes.
We sincerely regret
to inform you that
we have recently
learned that a small
number of the many
implant parts that
we manufactured may
have a trace of
lubricant residue on
the surface that was
not completely
removed during the
manufacturing
process.
We recently
discovered this
residue and
immediately and
voluntarily recalled
the affected
products. We have
teams of experts,
including
independent
scientists,
investigating this
issue. Based on
current information,
very small amounts
of residual
lubricants are
broken down and
eliminated by the
body. At the moment,
the only known
problem is not
enabling the bone to
bond with the
affected hip
implant. This
information is
currently being
confirmed with
independent
scientists. Surgeons
will be advised of
the results of this
investigation as
soon as possible.
The hip implant part
is the acetabular
"shell"
that is implanted
into the upper part
of the hip called
the acetabulum.
Normally, the bone
would form an
integrated bond with
the shell; however,
it appears that bone
does not always bond
with shells when the
lubricant residue is
present. Reported
symptoms include
severe groin pain
and inability to
bear weight on the
affected leg. These
symptoms are caused
by the shell being
loose from the bone.
Only a small number
of patients who
received the shell
during their total
hip replacement have
experienced
loosening of the
shell. Patients who
are experiencing
these symptoms are
encouraged to
contact their
physician.
Please note that our
surgeon advisors do
not recommend that
patients undergo
removal of the part
unless they exhibit
symptoms of
loosening.
We at Sulzer
Orthopedics
apologize for any
effect that this
voluntary recall may
have on patients and
surgeons. We will do
our very best to
address individual
needs and concerns
that are a result of
this recall. We know
that one of the
concerns of patients
will be the
additional costs
that may be incurred
because of further
medical attention.
Please be assured
that Sulzer
Orthopedics will
reimburse patients
for related
out-of-pocket
expenses not
reimbursed by
insurance or
Medicare.
We have set up a
toll-free telephone
number for patients
to call. The number
is 800-888-4676 ext.
232. Sulzer
Orthopedics has also
set up a toll-free
telephone number for
surgeons to call.
The number is
800-888-4676 ext.
296. Customer
service
representatives are
available to assist
patients
Monday-Friday from
7am-7pm Central
Time. Patients
calling after hours
may leave a message.
A customer service
representative will
return the call
promptly.
At Sulzer
Orthopedics, we are
dedicated to
improving the
quality of life by
advancing orthopedic
medicine. We are
committed to working
with surgeons to
provide information
needed to assure
proper diagnosis and
treatment is
available for each
patient affected by
this voluntary
recall of the
Inter-Op acetabular
shell. We are
determined to
maintain both the
integrity of our
products and the
professional
reputations of the
surgeons who use
them.
Please call our
toll-free numbers so
that we can address
your individual
needs.
Sincerely,
Gary Sabins
President, Sulzer
Orthopedics
