The Legal Examiner Mark The Legal Examiner Mark The Legal Examiner Mark search twitter facebook feed linkedin instagram google-plus avvo phone envelope checkmark mail-reply spinner error close
Skip to main content

In late 2009, the medical device company Smith & Nephew initiated a major global recall of its Oxinium Knee Implant products, marketed under the Journey knee implant system. Going on two years later, the effects of this recall are still being felt.

The recall was actually 44 different recalls for each manufactured product that have been problematic—namely the baseplates and inserts for the knee system in all of their sizes. A total of 38,750 units were included in the recall with distribution in the North America, South America, Europe, Asia, and Australia. Smith & Nephew initiated the recall after receiving complaints that the base plates were breaking after implant, which meant that patients needed revision—or replacement—surgery to repair the implant.

The company allegedly first notified the FDA of potential problems with the Journey implant system in 2003, at which point it also ceased new sales of the product. Only 6 years later did the firm finally recall products that were already out on the market.

Given the timeframe between the first notice to the FDA and the actual recall, it is likely that thousands of patients received this implant even though problems were known—and are possibly suffering pain or having to undergo revision surgery as a result. As with any medical device recall or issue, patients who received this product and are experiencing issues should seek advice from their physician and surgeon.

Comments are closed.

Of Interest