Sulzer Hip
On December 8, 2000, Sulzer Medica announced that it's subsidiary,
Sulzer Orthopedics, had issued a recall over certain manufacturing
lots of its Inter-Op acetabular shells for hip implants. The
recalled implants were sold primarily in the United States after
October 1999; a small number of lots sold after July 1997 were
also recalled.
According to the company, an oily residue was left on the surface
of some of its hip implant components because of a manufacturing
error. The oily residue may cause inflammation and pain and prevent
a patient's bones from fusing normally with the hip implant.
Symptoms caused by a loose connection between the implant and
the bone include severe groin pain and an inability of the joint
to bear weight.
Sulzer Orthopedics, Inc. is a subsidiary of Sulzer Medica, which
is headquartered in Winterthur, Switzerland and operated in America
by Sulzer Medica USA Holdings Company. Sulzer Orthopedics, Inc.
is a leading global designer, manufacturer and distributor of
orthopedic implants for hips, knees and shoulders. The company,
in conjunction with Sulzer Orthopedics, Ltd. in Switzerland, is
the fourth largest supplier of orthopedic implants in the world.
According to Sulzer Medica, one of every five hip implants used
today comes from these companies, which comprise the Orthopedics
Division of Sulzer Medica, a global network of medical device
companies.
As reported by Sulzer Medica, during testing of its Inter-Op
manufacturing process, an unacceptable percentage of the acetabular
components of the hip implant (the joint that connects the femur
to the pelvis) evidenced a residue of a lubricant on the exterior
porous surface of the implant shell. Sulzer Medica has reported
that its own specialists and scientists who are consulting with
Sulzer Orthopedics have concluded that this lubricant residue
may cause reactions in individuals with these implants due to
loosening of the implant shell, which may, in turn, necessitate
replacement of the implant.
Sulzer Orthopedics reports that since mid-September 2000 it
has received multiple reports of post-operative loosening of
a number of the Inter-Op acetabular shells. According to its
own investigation, approximately 17,500 products from the defective
hip implant lots have been implanted which 90% were put into
patients in the United States.
In early January 2001, Sulzer Spokesperson Jim Moore reported
that 91 people had defective hip implants surgically removed
and replaced. Further, Sulzer Orthopedics reports that it has
notified the implanting surgeons, the Food and Drug Administration,
and other regulatory agencies, and has implemented changes to
its manufacturing process to address the cause of this manufacturing
problem.
|
