TheSanDiegoChannel.com - Hip Replacements Recalled

Hip Replacements Recalled

Scientists Call Implants Safe

AUSTIN, Texas, 3:22 p.m. EST January 22, 2001 -- Independent scientists and former FDA officials have validated that Sulzer Orthopedics' Inter-Op Acetabular shells and manufacturing processes are clinically safe.

However, Sulzer, a global leader in the manufacture of joint implants, issued a voluntary recall of the hip replacement parts in early December because of a mineral oil residue on a percentage of their Inter-Op hip implant products.

During the manufacturing process of the Sulzer Orthopedics Inter-Op Shells, a mineral oil-based lubricant is used on the machines to allow them to run both cool and effectively. Sulzer identified 17,000 Inter-Op shells that were affected; some will require surgical revision in patients.

Surgeons who use Sulzer Orthopedics Inter-Op ace tabular products were quickly notified of the voluntary recall. The mineral oil-based residue that was discovered on the Inter-Op shells prevented the hip bone from attaching to the cup, leaving a gap between the implant and the actual bone. Within six weeks to three months after surgery, some patients who received a shell experienced significant pain and required a second surgery.

Sulzer Orthopedics has committed to paying all out-of-pocket expenses to patients whom insurance or Medicare won't cover for revision surgeries. The company has changed its manufacturing process to ensure that the problem doesn't happen again.

To eliminate the chance that machine lubricant could affect a shell, Sulzer Orthopedics has instituted two new cleaning steps and rearranged the sequence of its manufacturing processes. According to the independent scientific research, the new cleaning methods will produce Inter-Op shells that are cleaner than they have ever been.

Meanwhile, a Tampa woman filed suit Tuesday seeking class-action status against the manufacturer of an artificial hip.

Lawyers for 72-year-old Mildred Carlisle sued Texas-based Sulzer Orthopedics.

The lawsuit says the company was negligent in making and selling what attorneys call a "dangerous and defective product."

The company says Carlisle's suit joins four or five class action suits, plus about a half dozen individual suits.

For information on the Sulzer Orthopedic hip replacement recall, call (800) 888-4676 ext. 232. The phone line is staffed only during regular business hours. Or go to the Sulzer Orthopedic Web site.