Smith & Nephew plc Recalls Modular SMF, Modular Redapt Hip Implants

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Smith & NephewSmith & Nephew (NYSE:SNN) this week recalled its Modular SMF and Modular Redapt hip implants “due to a higher than anticipated complaint and adverse event trend” with the modular necks used in the devices.

“Based on an analysis of available data sets, 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,” the company wrote in a Nov. 15 “Dear Doctor” letter. “For this reason, on a precautionary basis Smith & Nephew is issuing a voluntary field safety corrective action for the modular neck hip prostheses.”

The recall does not include the Monolithic SMF and Monolithic Redapt implants, the British orthopedics and wound care giant said.

“Smith & Nephew has not received similar reports of metal-related complaints associated with these systems,” the company wrote in the letter.

Surgeons should monitor patients implanted with the Modular SMF and Modular Redapt hips for pain, swelling, limited mobility and enlarged bursa. Patients with these systems should have the level of cobalt/chromium ions in whole blood; metal ion levels above 7 parts per billion “may indicate the potential for soft tissue reaction,” putting further evaluation via ultrasound or other imaging scans on the table and increasing the level of monitoring to every 3 months.

“The need for any additional follow-up should be determined on an individual case-by-case basis following an assessment of patients’ clinical circumstances,” Smith & Nephew wrote in the letter. Pro-active revision surgery is not advised, the company said.

“Revision surgery should only be considered after a comprehensive examination of all the clinical findings, including blood work, imaging and especially if an adverse soft-tissue reaction is confirmed,” according to the letter.

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