Smith & Nephew, a manufacturer of artificial knees, announced a voluntary recall of its Oxinium Genesis II and Profix II knee systems. According to the company (see September 18, 2003, news release below), these non-cemented systems became loose after being implanted during knee replacement surgery.
Smith & Nephew is a London based company with its U.S. headquarters in Memphis, Tennessee.
Patients who received Smith & Nephew defective artificial knees may require revision surgery. Problems associated with the Smith & Nephew defective knees may include the following:
- Knee Pain
- Looseness of the femoral component
- Knee Revision
- Re-operations
- Risk of infection
- Joint and muscle problems
- Extensive rehabilitation
- Our firm is in settlement negotiations with representatives of Smith & Nephew, on behalf of some of our clients, and in discussions over the statute of limitations issues.
IF YOU HAD TOTAL KNEE REPLACEMENT WITH A SMITH & NEPHEW ARTIFICIAL KNEE BETWEEN FEBRUARY 2002 AND OCTOBER 2003, YOU MAY HAVE A CLAIM AGAINST THE COMPANY.
Knee implant recall hits Smith & Nephew
Geoff Gibbs
Thursday, September 18, 2003
The Guardian (UK)
Smith & Nephew, the medical products concern that lost out in the $3bn (1.8bn) battle for Switzerland’s Centerpulse, has suffered a further setback after deciding to withdraw a recently launched orthopedic implant from the US market.
The company said yesterday that it had stopped sales of the cementless versions of two of its knee systems because of a higher than expected number of follow-up operations.
According to a Smith & Nephew spokesman, about 30 of the 3,000 patients fitted with cementless versions of its Oxinium Genesis II and Profix II implants in the US have needed to have the procedure revised after the implants became loose. “One percent is not unusual in this industry but higher than Smith & Nephew would normally see,” the spokesman added.
He said the company alerted the US authorities after the problem first came to light last month and had decided to withdraw the products voluntarily for reasons of patient safety while it carried out a valuation to determine what was causing the problem.
Smith & Nephew shares dipped 7p to 400.75p but the company was insistent it did not face the sort of problem that hit Centerpulse some years ago when faulty joints resulted in $1bn of claims. “This is not Centerpulse mark II,” the spokesman said. The company had no knowledge of any legal action taken to date.
Knee implants account for about 200m of the group’s 1.2bn a year turnover but the products are withdrawn from the US market are believed to represent only 2m of sales.
Michael King, an analyst at WestLB, said the product withdrawal did not appear to be cause for alarm at this stage. But if the implant needed to be redesigned the delay could cause slower penetration rates of Oxinium into the knee market in the short term.
Product Liability suit filed against Smith & Nephew involving alleged defective total knee implants.
In February of 2002 orthopedic implant Smith & Nephew, placed on the market a “macrotextured” version of their Genesis and Profix Total Knee Systems. This macrotextured version contained a coating which was designed to allow surgeons to implant the femoral component of these devices without cement.
Despite the fact that this macrotextured coating was designed and created specifically to allow for the cementless implantation of these devices, the product was labeled “for cemented use only.” It is our belief that it was labeled as such in an attempt by Smith & Nephew to avoid FDA filing requirements. In fact, these implants were labeled and marketed outside the United States for cementless use.
At the time the macrotextured implants were placed on the market, no implant sold in the sold in the United States and treated with the Tecotex macrotexturing process, had gained clearance or approval by the F.D.A. Despite this fact, no PMA (pre-market approval) was ever filed with the FDA. In February of 2003, roughly a year after the product was placed on the market, a 510(k) was filed with the FDA. This 510(k) was subsequently withdrawn, as was the product in September of 2003
Pittman Dutton & Hellums attorney Chris Hellums filed suit on July 27, 2006, in the Circuit Court of Bibb County Alabama against Smith & Nephew and its sales representatives on behalf of Erma Jean Brooks and her husband. Mrs. Brooks underwent a total knee replacement surgery on September 5, 2002. She received one of the withdrawn cementless Smith & Nephew macrotextured implants. That implant failed and in December of 2005, she was forced to have revision surgery to remove the implant and install another implant. As a result of the revision surgery, Mrs. Brooks contracted a staph infection, which has resulted in her having the second implant removed and has forced her to be hospitalized since the summer of 2006.
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