Smith and Nephew recalls Modular SMF and Redapt hip implants
Posted by Shezad Malik MD JD
February 2, 2017 11:26 AM
Smith and Nephew recalls Modular SMF and Redapt hip implants. Late last year, UK-based medical device company Smith & Nephew recalled its line of Modular SMF and Modular Redapt hip implants after it received reports of premature failure and metal poisoning known as metallosis.
Metal on metal hip implants have a high failure rate including those manufactured by Biomet, DePuy, Encore, Smith & Nephew, Stryker, Wright and Zimmer.
Smith and Nephew “Voluntary Recall”Smith & Nephew issued an Urgent Field Safety Notice on November 15, 2016 with a list of affected lots and products. According to the notice, they “initiated a voluntary market removal for all lots of modular neck hip prostheses due to a higher than anticipated complaint and adverse event trend.
”What are the Modular SMF and Redapt hip implants?
The Modular SMF and Modular Redapt Hip System was approved for sale in 2008 and 2012, fast tracked through the FDA’s 510(k) process. Both implants have a modular cobalt chrome neck pieces that fit into titanium coated metal stems.Having been approved through the 510(k) process meant that the company did not have to present safety data, as long as the devices were substantially similar to other hip devices already in the market.Orthopedic doctors use the SMF model for primary and revision hip surgery and the Redapt model for revision surgery alone. Implants affected by the recall include those shipped from October 2008 through 2016.Metal-on-Metal Hip
According to Smith and Nephew, the metal-related injuries caused by the SMF and Redapt hips continued to increase with time.
The SMF and Redapt hip implants have titanium coatings and use cobalt-chromium neck stems. Cobalt-chromium hip implants have been shown to release cobalt and chromium ions into the body leading to metallosis.
These artificial metal hip implants are associated with high metal levels in the blood, severe pain, soft tissue reactions (pseudotumors), bone and tissue death.