The Smith & Nephew Birmingham Hip Resurfacing (BHR) hip implant system (approved in 2006), is commonly used by surgeons who want to preserve the patient’s femoral head. However, the BHR system has been found to create problems in patients who do not meet a very limited list of qualifications.
In Smith & Nephew’s 2015 BHR recall, officials issued a safety notice stating that patients over 65 and patients that required an implant head 48 mm or smaller experienced an increased risk of needing revision surgery. The also stated that the BHR implants created a risk for fractures, dislocation, and an assortment of other complications that could lead to revision surgery.
But the safety notice didn’t stop at that release. Shortly later, they released yet another notice advising surgeons to not implant the BHR in female patients and to not use BHR femoral head components less than 46 mm in size. According to sources, the BHR has a 26% failure rate in women after ten years. Additionally, patients who experienced injuries from a faulty BHR complained
of severe and persistent pain.
In 2012 Smith & Nephew instigated a worldwide recall for the R3 Acetabular System, a metal liner used in nearly 4,000 patients in the U.S. in 2009. The R3 Acetabular System, a modular hip implant system, is composed of several individual components for surgeons to select from based on what the patient needs: a femoral stem, femoral head, liner, and acetabular cup.
showed that patients experienced a number of complications including pain, loosening, device failure, infection, metal sensitivity, and dislocation. While the implant was highly marketed as a sturdy, long-lasting product, the numerous complaints instigated the recall 3 short years after its release in the United States.
Smith & Nephew released the Modular SMF Hip System in 2008 and was followed by the Modular Redapt Femoral System in 2012. However, they were both recalled at the same time in a Class II recall in November of 2016.
The FDA recall notes that the pull stemmed from “a higher than anticipated complaint and adverse event trend.” Complaints linked to these two systems correlate with those of the R3 and BHR, including high levels of metal particles in patients’ bloodstreams.