Smith & Nephew has announced a new recall for a modular neck hip prosthesis that is often used in conjunction with the company’s Modular SMF and Modular REDAPT Revision Femoral Hip Systems. According to an Urgent Field Safety Notice dated November 15th, Smith & Nephew is also removing related hip stems from the market.
According to the notification, the recalled components have been associated with a higher complaint rate than comparable monolithic hip prostheses.
“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.”
Patients implanted with the Smith & Nephew modular neck hip prosthesis may face a greater risk of revision surgery. Physicians have been advised to monitor patients for pain, swelling, limited mobility and enlarged bursa. Those exhibiting such symptoms should be considered for more extensive clinical evaluation, including blood testing to determine levels of chromium/cobalt ions, as levels in excess of 7pbb may indicate the potential for soft tissue reactions. Ultrasound or cross-sectional imaging may also be needed to further assess the patient for any soft tissue reactions.
Revision surgery should only be considered after a comprehensive examination of all the clinical findings, including blood work and imaging, is completed, especially if an adverse soft-tissue reaction is confirmed.
It should be noted that this action does not affect Monolithic SMF and Monolithic REDAPT Revision Femoral Hip Systems. Smith & Nephew has not received similar reports of metal-related complaints associated with these hip replacement systems.
Smith & Nephew’s recall comes just months after Stryker Orthopaedics announced a market withdrawal for certain lots of its LFIT Anatomic CoCr V40 Femoral Head components. The devices, which are used with some of Stryker’s modular hip systems, were associated with a higher-than-expected number of complaints involving taper lock failure. This issue has the potential to cause serious complications, including failure of the artificial hip and need for revision surgery.
The affected LFIT Femoral Heads are constructed from a chromium/cobalt alloy. They were manufactured prior to 2011, and were designed to be used with the following Stryker hip components: