Smith & Nephew describes themselves as a “global medical technology business” supporting healthcare professionals in over 100 countries. They specialize in joint replacement, advanced wound management, sports medicine and other orthopedic hardware and implants.
In Late 2016 Smith & Nephew sent issued an urgent field safety notice (link to PDF notice) and voluntary market removal for lots of modular neck hip prostheses. This market removal included Smith & Nephew’s Modular SMF and Modular Redapt hip implants. This recall was initiated “due to a higher than anticipated complaint and adverse event trend”. In the communication sent to medical professionals Smith & Nephew states “During a recent review of product complaints received by Smith & Nephew and clinical study data associated with the modular hip prostheses, we observed a rate of complaints higher that comparable monolithic hip prostheses.”
In January of 2017 the FDA issued a class 2 Device recall for almost 32,000 Smith & Nephew hip systems worldwide.
- 6,266 units of the Modular Redapt Hip Systems.
- 11,999 units of the Modular SMF Hip Systems.
- 13,671 units of Modular Necks.
The FDA class 2 device recall list the determined cause of the recall to be ‘Defective Design.” Smith & Nephew customers were notified and instructed to inspect inventory and quarantine any unused devices immediately. Patients and medical professionals have been urged to monitor the implant for localized swelling or enlarged bursa, limited mobility and pain. For individuals experiencing these symptoms Smith & Nephew recommends additional annual follow up for the lifetime of the patient.
The additional follow up should include the following:
- Cobalt/Chromium metal-ion level measurements in whole blood – metal ion levels in excess of 7ppb* may indicate the potential for soft tissue reaction; and
- Where appropriate and subject to the clinician’s assessment, further active evaluation of the potential soft tissue reactions either through ultrasound or cross-sectional imaging might be indicated.
Both the SMF and Redapt hip implant systems are metal-on-metal devices. Metal-on-metal devices are often associated with a severe condition call metallosis. Metallosis is caused when small particles of the metal break off of the implant components and enter the surrounding tissue. This can result in tissue death, pseudotumors, infections, bone death and organ failure. Patients who experience metallosis may require painful revision surgery to remove the affected tissue and bone as well as the implant itself. Often times recovery from a revision surgery is longer and more painful due to metallosis.
Our dedicated team of lawyers is available to serve you from conveniently located offices throughout New York State and Vermont, and our call centers are available day and night to help protect your rights.
If you or someone you know had a Smith & Nephew Modular SMF ™ Smith & Nephew Redapt ™ hip system, call us today for a free consultation and review of your legal options. Our attorneys take the Smith & Nephew hip replacement system recall seriously. You may be entitled to compensation for medical expenses, loss of enjoyment of life or pain and suffering. Call Martin, Harding & Mazzotti, LLP to speak with an experienced Smith & Nephew hip implant lawyer 24/7 at 1800LAW1010 (1.800.529.1010).