Sulzer Hip Recalled
A manufacturing error in the production, one that left machine oil on hip joint replacements has forced the company to recall nearly 25,000 hip implants. Unfortunately nearly 17,500 of these products have already been implanted in patients. Nearly 90% of the patients are United States citizens. The company has been criticized for failing to take action sooner. According to Sulzer's own press release, they suspected problems in October 1999, yet waited over a year to announce its recall on December 8, 2000. During that year, surgeons around the country noticed patients with Sulzer implants were having more difficulty than usual. As the findings grew, the company was forced to acknowledge the enormity of the disaster.In late January 2001, the company's stock price had plunged with the realization that thousands of claimants may seek redress under US products liability law. No one knows how many people may need revision surgery, but the numbers appear daunting. One California hospital has identified 254 patients who have been having serious problems with the recalled implant. The legal claims typically involve what is called strict liability for a defective product, breach of warranty, negligence and strict liability for failure to warn recipients in a timely manner of the defect. Several lawsuits have already been filed around the country.
Sulzer Hip Implants: The problemThe socket portion of the implant has a machine oil residue that prevents it from adhering to the patient's hipbone. These sockets do not allow the patients body to heal properly and the oil prevents the bone from growing and grafting into place. These sockets are so-called "force fit" -- that is, they snap into place and the bone is supposed to grow to it. An alternate technique to cement the socket to the bone is more often used in elderly patients, cemented implants are not the type subject to the recall.
Sulzer has listed some of the symptoms patients experience with a recalled Inter-Op shell implant:
Up to 6 weeks after hip replacement surgery:
The patient may be progressing well or reporting groin or anterior trochanteric pain;
The patient may have increased thigh pain;
The patient has significant startup pain with ambulation (walking) or, rising from a seated position, may have buttock pain; and
An x-ray may show possible component migration.
6 weeks to 3 months after hip replacement surgery:
The patient may experience significant pain with weight bearing, and may require a cane or crutch; and
The patient may be unable to exert resistance in a straight raised leg test and a side-lying abduction test.
Many patients experience debilitating pain and are unable to stand or walk unaided.
A second revision surgery will take twice as long and carries more risk than the initial implant. There is more scar tissue and the body does not heal as easily
According to the American Academy of Orthopedic Surgeons, there are around 310,000 people in the United States that undergo partial or full hip replacements each year. It is considered major surgery, though a 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 recall involves 17,500 hip replacement units, nearly a full year's production. One month into the recall, some 129 patients have already undergone "revisions" -- replacements of the replacement.
Lawsuit FiledA patient with the recalled implant filed a lawsuit on Friday, January 19, 2001, in the Superior Court for the State of California, in the County of Alameda. The claims against Sulzer include allegations of strict liability for manufacturing a defective product, breach of warranty-the product is not fit for the purpose for which it was intended, negligence and strict liability for failure to warn. The complaint seeks to recover for all damages that the patient has suffered as a result of the implant of the allegedly defective shells.
Damages sought against Sulzer include: All pain and suffering; associated with the recall implant; all past and potential future medical expenses associated with the allegedly defective hip implant; and all loss of earnings and/or earning capacity associated with the surgery.
Sulzer Inter-Op Shells Recalled | Overview of the Recall | News | Sulzer Hip Replacement Forum
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