Hip surgery is invasive and painful, and recovery requires dedication. So an announcement that Sulzer Orthopedics was recalling some of the parts used in hip implants has created some distress and misunderstanding.
But Utah doctors, including a number who implanted hip sockets that were part of lots recalled by Sulzer Orthopedics (a subdivision of Switzerland-based Sulzer Medica) in late November, say the number of people affected is small.
And most of the people who did receive an implant involving one of the potentially defective hip sockets needn't be concerned, although a small percentage will need to have the hip replacement replaced.
"Because of the invasive nature of the surgery and the recovery, we're telling people not to do anything unless there's a problem, like pain in the inner thigh," said Jess Gomez, spokesman for LDS and Cottonwood hospitals.
The recall centers on Sulzer's "Inter-Op acetabular shells for hip implants." Most of the affected shells were sold in the United States after October 1999, though a few go back to July 1997.
A small amount of mineral-oil lubricant that was left on the exterior porous surface of the shell appears to have, in "random cases" prevented the shell from bonding with the bones. The company by mid-January had reported 129 confirmed cases where the shell had loosened, out of roughly 17,500 products implanted from the affected lots.
Symptoms that the hip's shell might be coming loose include severe pain in the groin and an inability to bear weight on that leg. Sulzer asks that anyone with those symptoms, whose hip replacement shell came from the affected lots, contact his or her physician to have it checked.
So far, there haven't been many such requests, according to Dr. Aaron Hofmann, an orthopedic surgeon and professor in the department of orthopedics at University of Utah Medical Center.
"This thing is so blown out of proportion," he said. "So many patients are worried about this."
Last year, Hofmann said, 250,000 hip replacements were performed nationwide. There are 10 manufacturers who make the artificial hip joints that are used. The recall affected only one manufacturer and only a small segment of its product line. Furthermore, of that small segment, "only a small number are defective."
Orthopedic surgeons contacted by the Deseret News say they've already talked to most of their patients who received one of the hip shells from the recalled lots.
Hofmann said he has 73 "at-risk" patients, meaning patients who received hip parts from the now-recalled lots. So far, none of his patients has needed to consider having a hip revision, the surgery that would replace the defective joint. "The bottom line is, everyone who is at risk is not going to have problems."
None of the hip replacements at LDS Hospital involved the lots that were recalled, but close to 60 at The Orthopedic Specialty Hospital at Cottonwood did. And only a small number of those will require any follow-up treatment at all, Gomez said.
Under the recall, Sulzer has told doctors not to use hip replacement parts from the affected lots. But the company, too, counsels patients who aren't having problems not to worry about it. Because fewer than one-half of 1 percent of those who received the hip shells have reported any pain or difficulties, the recall is voluntary and precautionary, the manufacturer said.
Sulzer has set up a toll-free line to take calls from patients with questions about the recall: 1-800-888-4676, extension 232.
E-mail: lois@desnews.com