“The implant is called the “DEUCE” (sic) because it replaces only the two areas of the knee most commonly affected by osteoarthritis while keeping the third area intact. Since 2003, 1.8 million Americans have had their ACL replaced, which can lead patients to feel instability and abnormal motion in their knees. But now JOURNEY DEUCE (sic) Knee System offers another important benefit and allows the surgeon to keep their patient’s anterior cruciate ligament (ACL) intact.”
Three years later, in 2010 Smith & Nephew recalled a component of the Journey Deuce system. Lucy Campbell, a writer with Online Legal Media, reported that the Journey Deuce Uni Tibial Baseplates, which rest on the tibia and attaches to the knee replacement hardware on the femur, were found to be prone to breaking, thus compromising the entire knee replacement, which could become unstable.
Indeed, according to a study archived in the US National Library of Medicine and the National Institutes of Health, the Journey Deuce was found to have a high failure rate.
“The advantages of the Journey Deuce system compared to total knee arthroplasty (TKA) are the bone sparing and cruciate retaining implantation,” the study authors wrote. “Outcome studies and investigation with respect to success and revision rates are rare. Thus the aim of this study was to investigate the early functional outcome as well as the revision and complication rates in patients with Journey Deuce prosthesis within the first 2 years.”
The German study, completed in November 2012, concluded that “under clear indications and exact anatomical positioning the Journey Deuce prosthesis enables a good functional outcome; however, a high revision rate occurred in this study caused by technical complexity and insufficient variety of implant sizes which led to malalignment and instability.”
In the same year the Smith & Nephew Journey Deuce was approved, a clinical study was launched comparing the functional performance of the Smith & Nephew Journey Deuce Bicompartmental system as compared with the Genesis II Total Knee System. Involving 50 participants, the study was initiated in September, 2007 and continued for almost six years until its conclusion in May, 2013. Results of the clinical study, sponsored by the Anderson Orthopaedic Research Institute, were published in 2014 with the most recent update dated August 4 of that year. While various results are broken out, the document did not include a conclusion in the online post.
While all this was going on Smith & Nephew was before the US Food and Drug Administration with regard to the approval of instrumentation (instruments) for the Unicompartmental and Bicompartmental Knee System. The date of the summary is November 29, 2011 – a year after the 2010 recall. And the instruments were being considered for approval under a 510(k) Clearance, the fast-track protocol available from the FDA to approve devices that are substantially equivalent to devices already on the market and performing satisfactorily.
“The device specific instruments associated with the implant devices with which they are used are considered substantially equivalent to previously cleared device specific instruments in that both subject and predicate instruments: Share the same raw materials; Are manufactured though the same processes; Utilize the same sterilization procedures; and have similar nature of body contact,” the Summary of Safety and Effectiveness states.
“The Smith and Nephew Unicompartmental and Bicompartmental Knee System Instruments are similar in design and function to competing uriicompartmental and bicompartmental surgical instrumentation currently on the market.”
It is not known if the Smith & Nephew Journey Deuce System and specifically the recalled Journey Deuce Uni Tibial Baseplates were originally approved under a 510(k) clearance. However, various critics have long called for the abolishment of the 510(k) protocol, holding the view that any advantage towards getting devices to the market faster, are offset by a proliferation of inadequately-tested devices that demonstrate high rates of failure.