Smith & Nephew Hip Recall Issued Due to Problems with Modular SMF, Modular REDAPT Systems

Amid higher-than-expected reports of problems with certain artificial implants, a Smith & Nephew hip recall has been issued for Modular SMF and Modular REDAPT Revision Femoral Hip Systems, removing the associated stems from the market due to a risk of high failure rates and adverse events. 

The medical device manufacturer sent a “Dear Doctor” letter to medical providers earlier this month, announcing a “voluntary field service corrective action” for the modular neck stems, indicating that the overall complaint rates are at 0.527% for the Modular SMF and 0.25% for Modular Redapt Revision Femoral Hip Systems.

The highest number of Smith & Nephew hip problems have been linked to metal debris shed from the recalled components, the letter states.

“In the worst case scenario implanted patients are symptomatic and exhibits adverse tissue reaction to metal debris which may lead to revision surgery,” the letter warns.

The recall affects all lots of modular neck hip prostheses used with the Modular SMF and Modular Redapt Revision femoral hip systems. The recalled components were shipped between October 2008 and July 2016.

Doctors are being urged to monitor patients who received the implants, looking for signs of pain, swelling, limited mobility and enlarged bursa. If symptoms are detected, Smith & Nephew recommends that doctors check for levels of cobalt and chromium metal ions in the blood every three months. Levels exceeding 7 parts per billion may be signs of a tissue reaction.

The manufacturer also recommends that doctors then look for soft tissue reactions through either ultrasound or cross-sectional imaging.

The Smith & Nephew Modular SMF and Modular Redapt have been found to release microscopic metallic debris as the parts rub against each other. This has been linked to reports of loosening and failure, often within a few years after the artificial hip is implanted.

The company is not advising doctors pro-actively remove the Smith & Nephew modular hip implants, unless a problem is detected. However, many consumers are likely to incur additional medical expenses and face a serious risk of complications the longer the devices remain in their body. Therefore, it is likely a number of Smith & Nephew hip recall lawsuits will be filed in the coming months, seeking both medical monitoring and compensation for premature hip failure that may have occurred.