Knee Implant Recall Hits Smith & NephewMar 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 orthopaedic 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 per cent 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Knee implants account for about £200m of the group's £1.2bn a year turnover but the products withdrawn from the US market are believed to represent only £2m of sales.
Michael King, 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.