The Modular SMF Hip System and Modular REDAPT Revision Femoral Hip System are marketed by Smith & Nephew. In November 2016, the company announced a recall for a modular neck hip prosthesis frequently used with these two hip replacements, after they were linked to a higher than expected rate of metal-related complaints.
Smith & Nephew’s Modular SMF Hip System is indicated for uncemented use in individuals undergoing primary and revision hip surgery due to:
The Modular SMF Hip System is marketed by Smith & Nephew to offer surgeons “an improved bone conserving modular neck implant.” The system features proximally porous coated titanium alloy tapered femoral stems that are designed to be compatible with the company’s high-demand femoral head bearing options.
Smith & Nephew’s Modular REDAPT Revision Femoral System is indicated for use in hip revision surgery, and features an adaptable design that allows surgeons to achieve the best stem fit without compromising stem strength. The REDAPT system also enables the surgeon to attain joint stability via independent adjustment of neck angle, height, offset and version.
Modular-neck hip implants like the Smith & Nephew SMF and REDAPT hip systems have an interchangeable part between the femoral stem and the femoral head. This configuration creates a “metal-on-metal” design that may result in the shedding of toxic ions into the tissue surrounding the hip implant. This action can result in adverse local tissue reactions, metallosis (metal poisoning), bone loss, and premature device failure, all of which may result in the need for revision surgery.
In November 2016, Smith & Nephew recalled a modular neck hip prosthesis, along with certain Moduar SMF and Modular REDAPT hip stems, due to a higher complaint rate in comparison to similar monolithic hip prostheses. All of the components included in the Smith & Nephew hip recall were sold between October 2008 and July 2016.
“Metal-related complaints are trending upward year-on-year with an overall complaint rate (number of complaints/total implantations) of 0.527% for Modular SMF and 0.25% for Modular REDAPT Revision Femoral Hip Systems,” Smith & Nephew said. “Overall, the metal-related Adverse Events accounted for the highest category of complaints in both products.”
Individuals fitted with the recalled Smith & Nephew modular neck hip prosthesis and hip stems may be at increased risk of revision surgery. Physicians have been advised to monitor patients for pain, swelling, limited mobility and enlarged bursa. Patient exhibiting these symptoms should be consider for metal ion blood testing, and possibly imaging screens, to determine the potential for soft tissue reactions.
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