December
19, 2000
Dear
Patient,
Sulzer
Orthopedics is the
manufacturer of a
hip implant that you
received during hip
replacement surgery.
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 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. Your
surgeon will be
advised of the
results of this
investigation.
The
hip implant part is
the acetabular
"shell"
which was implanted
into the upper part
of your 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 your
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. If you are
experiencing these
symptoms, please
contact your
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 you. We will do our very best to address your individual needs and concerns that are a result of this recall. We know that one of your concerns will be the additional cost that you may incur because of further medical attention. Please rest assured that Sulzer Orthopedics will reimburse you for your related out-of-pocket expenses not reimbursed by insurance or Medicare. Sulzer Orthopedics is dedicated to resolving any healthcare problems associated with this implant recall and will cover any costs involved…
This letter can be found at: http://www.sulzerorthopedics.com/us/recall/InterOp_message.htm
