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Hip replacement patients may face more surgery

17,500 hip units recalled

Sulzer Orthopedic has recalled thousands of hip replacement units like this one  

OAKLAND, California (CNN) -- Rhonda Silva used to take long walks with her husband. Now she's confined to her Oakland, California, apartment, immobile for ten months with defective hip replacements that cause her "excruciating pain."

"I feel like I have an alien living in my body," she said.

The active and athletic 48-year-old public relations executive had her left hip replaced in April, 2000, after being diagnosed with osteoarthritis. But after six weeks of recovery and physical therapy, the hip failed to heal.

"By June, I was told that I wasn't progressing and the physical therapist said, 'We don't know what to do for you.'"

Silva sought her doctor's opinion -- then, at his urging, a second opinion. Both were the same: Replace the replacement.

Silva underwent that surgery in October, but more bad news arrived just before Christmas. Her doctor was notified that replacement, too, was defective.

"He said 'Come to my office and I need to talk to you and you might want to call your husband,'" she recalled.

Silva, who is scheduled for her third surgery on the same hip next month, is anxious, angry and apprehensive.

"I lie in bed at night and so panicked, and I've had a couple of anxiety attacks just knowing I have this device."

Will the third time be a charm, or merely more pain and disappointment?

"I know what's in store for me when I have the operation and dealing with that aftermath again."

Estelle Knowland, of nearby Alameda, California, also has the same defective hip replacement, but has not been told if she will need another hip replacement.

"It's a major surgery with hospitalization and rehabilitation, learning to walk again. And a lot of pain."

Pain is what Silva feels the most.

"The beginning and the end of the day are the toughest parts because they're the most painful. So to get out of bed is the most excruciating." Doctors agree that those with damaged hips have the most difficulty getting in and out of bed because of the bending and pressure the movement places on the hip joints.

Silva's orthopedic surgeon, Dr. Mac Reynolds, has notified 250 of his patients of the defective hip replacement.

"Devastating. Devastating. We see the gamut of emotions from people bursting out and crying to people being angry, to people storming out."

Not all come back.

"A hip replacement is a life-changing, life-altering operation to make people better and it's difficult to get them back for the second operation sometimes," Reynolds said.

The problem

The socket portion of the implant was determined to have an oily residue that prevented it from adhering to the patient's hipbone. Some sockets are so-called "force fit" -- that is, they snap into place and the bone is allowed to grow and graft to it. An alternate technique to cement the socket to the bone is more often used in elderly patients.

The implant's manufacturer, Sulzer Orthopedic of Austin, Texas, said it began receiving notices from doctors of problems with the implants in September, 2000, and immediately checked patient records, surgical techniques, therapy regimens and, ultimately, the product itself. The company ordered the recall after an 8-week investigation, according to Sulzer general manager Steven Whitlock.

"It's not a fault of the surgeon, it's not a fault of the patient. It was ultimately a fault of one of our products, and we're taking full responsibility for that," he explained.

Rhonda Silva has had two hip replacements and is scheduled for a third  

The recall involves 17,500 hip replacement units, nearly a full year's production. One month into the recall, some 129 patients have undergone "revisions" -- replacements of the replacement.

Whitlock added that he has heard of cases like Silva's where a third surgery is needed.

"We accept full responsibility for that. We're sorry that occurred. We would like to and have communicated to the patient we would like for them to not incur any out of pocket expenses associated with this recall."

Sulzer has changed its manufacturing process to ensure that the oil residue found on the recalled implants is not present on newer units, according to Whitlock.

"We have instituted changes in the manufacturing process. We have validated those changes and what we're producing now are clean parts."

Patients who have had the socket cemented in place are not affected by the recall -- their implants should function normally.

Sulzer has set up a web address for doctors and patients who have questions about their hip implants. Products made by other companies are not involved in the Sulzer recall.

The American Academy of Orthopedic Surgeons reported that around 310,000 people in the United States undergo partial or full hip replacement each year. It is considered major surgery, though now a very common one. Sulzer is a major manufacturer of hip implant devices. Its replacement femoral stem -- the long part that attaches to the leg bone -- is used in about one-fifth of U.S. hip replacements. Overall, Sulzer's full hip replacement business makes up about 11 percent of the market, the company said.

At least one lawsuit has been filed against Sulzer in connection with the recall and others are expected.

San Francisco attorney Don Arbitblit disputed the company's timeline.

"They were receiving reports of loosening of this hip implant device since at least October 1999," he said. However, the company said it did not begin hearing about the defect until much later.

A National Institutes of Health panel reported last year that more study should be done on what happens to medical devices after they are implanted in patients. The panel said the research was essential for making improvements to artificial joints, pacemakers and other implants.

Estelle Knowland does not yet know if she'll replace the replacement, while Rhonda Silva wondered if it could be any more painful than the defect she carries now.

"I'd like to walk down the street holding my husband's hand instead of a crutch or a walker. I just want my life back."

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Sulzer Orthopedics
American Academy of Orthopedic Surgeons - Hip Fractures
National Institute of Arthritis and Musculoskeletal and Skin Diseases - Hip Replacement
WebMD - Hip joint replacement

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