Smith & Nephew Modular SMF and Redapt Components Recalled
Modular SMF and Redapt Hip Devices
Two Smith & Nephew modular hip devices have been voluntarily recalled by the company. In a November 15, "Dear Dr." letter, the company reported that patients with the modular SMF and Redapt devices are at greater risk of needing revision surgery compared to those with Smith & Nephew's monolithic hip device system. As a result, approximately 90 metal hip components from Smith & Nephew's modular SMF and Redapt hip devices have been affected by the recall. Both the neck components and associated femoral stems are included in the recall.
How is the Device Failing?
The problem with these devices is between the neck and stem (creating a modular neck component) both of which are made of metal. As we've seen with other metal-on-metal modular devices, friction and chemical reaction between the metal components are leading to corrosion, shedding of metal ions into the body, and need for revision surgery.
The company also reported that metal-related Adverse Events accounted for the highest category of complaints in both the modular SMF and Redapt. Doctors are being urged to follow up with patients to monitor them for pain, swelling, and enlarged bursa. Additionally, doctors should test for high metal levels. The company acknowledges that if metal ion levels are above 7 parts per billion, it "may indicate the potential for soft tissue damage". Damage to surrounding soft tissue will require revision surgery, is extremely painful, and is also an overall detriment to the patient's quality of life.
GoldenbergLaw is experienced in handling metal-on-metal hip claims. Our firm is familiar with the hip device manufacturers, product designs, mechanisms of failure, and injuries sustained by clients. We've helped clients file claims and receive compensation from orthopedic giants such as Stryker, DePuy, and Biomet. Call us toll free at 844-680-6100 or fill out our form in the sidebar for your free consultation.