Lawsuits Filed Over Hip Implants That Failed to Attach to Bone

At least 341 people have required surgery after receiving faulty prosthetic hips, leading to a class-action lawsuit Tuesday in San Francisco against the manufacturer, several other legal actions and a recall of unused devices.

The prosthetic hips, manufactured by Sulzer Orthopedics, were implanted in thousands of patients throughout the United States from 1997 to late 2000. According to patients and attorneys who are suing the company, they sometimes fail to attach to patients’ bones, rendering their legs nearly useless and prompting severe pain in the groin, leg or hip area.

“I was told if I had this hip replacement I’d be as good as new,” said arthritis sufferer Rhonda Silva, one of about 15 plaintiffs in a class-action suit filed in San Francisco against Sulzer on Tuesday. “It’s ruined my entire life.”

The Austin, Texas-based company in December voluntarily recalled thousands of the prosthetic hips not yet implanted in patients, and it has told doctors to replace only those prostheses that have failed. The device is known as the Inter-Op hip shell.

Sulzer, which also has headquarters in Switzerland, has apologized to patients and last month revamped its cleaning procedures to make sure that residue is not left on its prostheses. The company makes about 12% of the artificial hips used in the United States.

The problems have been scattered throughout the country, although a significant number of the potentially damaged prostheses were distributed in Texas, Florida, Arizona and California, a Sulzer spokesman said.

Lawsuits have been filed in several other states besides California.

The company blames a new manufacturing process, which left an oily residue on an unknown percentage of the 17,500 high-tech Sulzer hips that doctors have implanted since 1997. The residue is said to prevent the devices from properly bonding to patients’ bones.

“The oil fills the pores [in part of the prosthesis] and it’s like trying to attach something to an oily chalkboard,” said Robert Romano, a Teaneck, N.J., attorney whose firm has also filed a class-action suit. “You’re just not going to be able to get a grip.”

Silva and the other plaintiffs in the San Francisco suit are seeking unspecified damages from Sulzer, along with funding to monitor the medical conditions of patients who have not displayed symptoms of faulty hip replacements.

The plaintiffs will try to find out exactly when Sulzer knew about the problem, said Richard Heimann, the San Francisco-based lead attorney.

“We had some reports from physicians of this phenomenon occurring, and so we looked into it,” Sulzer spokesman Jim Johnson said.

According to both Romano and the company, symptoms that an artificial hip has not properly grafted to a patient’s pelvic bone usually begin to show up within three to six weeks of surgery, although it can be as long as six months.

Key signs, Romano said, are pain in the groin, inner thigh and buttock, as well as pain while walking or putting weight on the hip. Another sign is the inability to exert resistance with the leg.

Perhaps because it was marketed as a device that lasts longer than most hip replacements, a significant number of middle-aged arthritis sufferers have been affected, along with elderly patients.

Silva, of Oakland, had exercised daily and run a small company before a crippling case of arthritis forced her to walk with a cane. There was just one cure, her doctors said: a hip replacement.

But a few weeks after the 48-year-old public relations executive had the surgery last April, she said, she collapsed in pain more excruciating than any she had ever felt. Somehow, she said, the synthetic hip that had replaced her own deteriorating joint had separated from the pelvic bone to which it had been grafted. Her leg was no longer fully anchored to anything within her body.

Her doctors recommended another cure: Replace the replacement. But Sulzer had not yet recalled the faulty hip and Silva’s new hip came from the same batch as her old one, she said. The operation failed again.

Now, Silva is scheduled for a third surgery--with a new doctor whom she has instructed not to use a Sulzer hip.

Cherie Lewis, who is also a plaintiff in the San Francisco lawsuit, was progressing well after her Oct. 30 hip replacement in Contra Costa County, where she lives and works as a sales manager.

Like Silva, she was working with a physical therapist, and she had almost reached the point where she was allowed to put her full weight on her new hip.

Then, on the Sunday before Thanksgiving, she woke up in pain. Her doctors didn’t know what it was, she said. They increased her dose of painkillers and told her to cut out the physical therapy.

It wasn’t until December, Lewis said, that she learned about the faulty hips. She received a replacement hip last month.

The U.S Food and Drug Administration is monitoring the recall to make sure that Sulzer is taking the proper steps to remove the problem prosthetics from the market. FDA spokeswoman Sharon Snider said the regulatory agency learned about the faulty hips from officials at Sulzer.

“We’re in touch with the company, and we’re looking to see what their recall strategy is and whether it’s adequate,” Snider said.

(BEGIN TEXT OF INFOBOX / INFOGRAPHIC)

Artificial Hip Recalled

Sulzer Orthopedics, a manufacturer of artificial joints, is recalling one of its prosthetic hip implants--the Inter-Op hip shell. How the implant works:

*

Hip implant replacement surgery creates an artificial joint that imitates the ball-and-socket structure of the hip joint.

*

The surgeon inserts a shell with a smooth plastic lining into the pelvis socket.

*

The ball part of the thighbone is replaced with a metal ball mounted on a stem, which is fitted into the thighbone.

*

The implant is supposed to integrate with the natural bone structure. The part being recalled is Sulzer’s metal shell, which in some cases is failing to attach to patients’ bones. *

Source: Sulzer Orthopedics