Feb. 15, 2011

Smith & Nephew "Journey" base plates lead to "unacceptable" results that are significantly worse than alternative knee implant products, according to a study presented at a 2011 conference of surgeons.

More than half of patients studied said they would never choose the same product and surgery again.

The study reports that 39% of sugeries had a "poor" result.

Initial Experience of the Journey-Deuce Bicompartmental Knee Prosthesis (2011 AAOS Conference)

Smith & Nephew has recalled nearly 40,000 Journey Uni Tibial Baseplate knee devices due to a defect causing broken base plates in patients.

The product name is "Journey Uni Tibial Baseplate," (Medial/Lateral). One recall included 38,750 units. A later recall added another 628 units to the list.

As noted in the FDA bulletins on the recall, the firm has received complaints of the base plates breaking in situ. If a breakage occurs, the broken baseplate must be revised and/or changed. If left unrevised a broken base could lead to instability and premature wear of the construct.

Smith & Nephew Journey base plate recalls

The London-based medical device manufacturer Smith & Nephew recalled two of their Oxinium knee replacement products. Smith and Nephew stopped sales of the products and alerted U.S. authorities of the problems associated with the knee implants in August, 2003.

Smith and Nephew announced a voluntary recall of the cementless versions of their Oxinium Genesis II and Oxinium Profix II knee replacement systems. The London-based company reported that corrective follow-up surgery was needed for about 30 of the 3,000 patients fitted with the products in the United States, according to information first published in the British publication The Guardian.

Knee implant products make up approximately $370 million of the global corporation's annual revenues of $2.2 billion (based on Feb. 8, 2003, conversion rates from U.K. pounds). The specific knee implant products recalled are believed to account for approximately $3.7 million of sales revenue.

Most recalls of defective medical devices in the United States are voluntary actions taken by the manufacturer, although the U.S. Food and Drug Administration can force a recall if the manufacturer declines to remove a defective product from the market voluntarily.