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.
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 Design Complications
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.
Smith and Nephew Modular SMF and Redapt Hip System “Greater Risk”
Smith & Nephew found “patients implanted with the modular neck hip prostheses may be at greater risk of revision surgery than with comparable monolithic products.”
Smith and Nephew Hip Failure and Recall Lawsuits
Metal-on-metal implants like the SMF and Redapt are under fire after many medical studies found these implants cause early hip failure complications caused by metal debris being chipped off the implants.
By 2012, the UK’s Medicines and Healthcare Products Regulatory Agency, the U.S. Food and Drug Administration and Health Canada issued medical device alerts of these hip implants.
According to the FDA, “Reports in orthopaedic literature, data from international orthopaedic implant registries and presentations from professional/scientific meetings…have increasingly noted complications and potential problems of early failure of MoM hip systems, often requiring revision surgery.”
Metal on Metal hip lawsuits and settlements
- Johnson & Johnson’s DePuy settled ASR hip claims for $4 billion
- Smith & Nephew settled over $203 million for metal-on-metal hip claims
- Biomet settled over $56 million for M2a Magnum hip claims
- Stryker settled Rejuvenate and ABG II lawsuits for over $1.4 billion
- Wright Medical settled Conserve hip claims for over $240 million
If you think you may have any of the above hip implants including Smith & Nephew Birmingham Resurfacing, R3, Modular SMF and Redapt devices and are experiencing pain caused by metal corrosion or have suffered premature hip failure requiring full revision and emergency care, please call us.
Shezad Malik is an Internal Medicine and Cardiology specialist, a Texas Medical Doctor (retired) and Defective Medical Device and Dangerous Drug Attorney. Dr. Shezad Malik Law Firm has offices based in Fort Worth and Dallas and represents people who have suffered catastrophic and serious personal injuries including wrongful death, caused by the negligence or recklessness of others.