My recent experience with the voluntary recall of the Sulzer Orthopedics
Inter-Op acetabular shell for total hip arthroplasty caused
me to reflect on the need for timely dissemination of information
when a total joint implant fails.
Sulzer Orthopedics recalled certain manufacturing lots of its Inter-Op
acetabular shell on or about December 5, 2000, as a result of reports,
since mid-September 2000, of early loosening of the shell.
The company has now stated that extensive investigation revealed
that the loosening was related to a reaction of the body to a slight
residue of a lubricant used in the manufacturing process. This lubricant
was identified on the exterior porous surface of the shell in certain manufacturing
lots sold primarily in the United States after October 1999, with
a small number of lots sold after July 1997. Approximately 17,500
acetabular shells from the affected lots have been implanted, and
90% of them have been used in the United States. Sulzer
notified the implanting surgeons on or about December 5, 2000.
Between October 1999 and December 2000, I implanted thirty affected
Inter-Op acetabular shells. I began to notice complaints of groin
pain at two to four months after the total hip surgery in some of
these patients. At the time of writing, I had revised fifteen of
these acetabular shells.
My question to the orthopaedic community is, how do we best disseminate
information regarding early implant failure in a timely manner so
that all orthopaedic surgeons are aware of potential catastrophic
failure of a particular implant? Some of my patients with a defective
acetabular shell commented that the experience brought to mind the recent
Bridgestone/Firestone tire recall and the questions that
were asked: "Who knew what, and when was it known?"
We all like to make informed decisions on the basis of hard science.
However, I would venture to say that Sulzer Orthopedics suspected
that there might be a problem with the Inter-Op shell in mid-September
2000, when they started receiving reports from orthopaedic surgeons
about early acetabular loosening and failures. Obviously the company
was going to wait until they had a "significant" number
of failures before they recalled any implant and, to their credit,
they probably investigated this problem in a prudent and timely
manner. However, should not there be a system whereby the same orthopaedic surgeons
could have communicated or dispensed this information to all other
orthopaedic surgeons early on? Is it not incumbent upon us as orthopaedic
surgeons to communicate with each other? In this day and age of
personal computers, the Internet, and rapid electronic dissemination
of information, could not a system be set up whereby reports of
early and possibly catastrophic implant failures are e-mailed
to orthopaedic surgeons across the country? If the company manufacturing
the implant has information regarding early failure, should not
the orthopaedic surgeon who is inserting the implant also have this
information? I, for one, would rather have the information and have
to decide what to do with it than not have the information at all.
These are thought-provoking questions about which there will be
genuine disagreement. However, I believe that we need to reflect
on these issues, and I hope that this Orthopaedic Forum will generate
more discussion and possible solutions in the future.