Smith & Nephew, a British orthopedics and wound care company, has issued a recall of its Modular SMF and Modular Redapt hip implants after a high number of patients began reporting adverse negative reactions. The metal designs used a modular neck that has been linked to a “higher than anticipated complaint and adverse event trend.”
“Based on an analysis of available data sets,” the company wrote in a “Dear Doctor” letter last November, “Smith & Nephew considers that patients implanted with the modular neck hip prostheses may be at greater risk of revision surgery than with comparable monolithic products. For this reason, on a precautionary basis Smith & Nephew is issuing a voluntary field safety corrective action for the modular neck hip prostheses.”
Patients who have received the Modular SMF and Redapt hip implants have complained of pain, swelling, limited mobility and enlarged bursa, as well as elevated levels of cobalt/chromium ions in the blood.
Cobalt toxicity is a serious risk for metal-on-metal hip implant recipients, leading to potential heart, hearing and vision damage. Metal poisoning is not uncommon, as well. The debris shed from the metal scraping against metal has been linked to bone erosion and damage to surrounding tissue.
Medical device manufacturers of metal-on-metal hip implants, such as Wright Medical, Stryker, and Zimmer Biomet Holdings have been facing hundreds of lawsuits alleging faulty design. Johnson & Johnson and its subsidiary, DePuy Orthopaedics have recently been hit with a $1 billion verdict in a six-plaintiff bellwether trial only months after a $500 million verdict, which was ultimately reduced to $150 million under a Texas legal punitive damages cap.