Smith & Nephew’s Tandem Bipolar Hip is a comprehensive partial hip replacement system purportedly designed to “simplify implantation and minimize concerns for wear.” In August 2016, Smith & Nephew announced a recall for certain batches of the Tandem Bipolar Hip System due to a manufacturing defect that could lead to detachment of the device after surgery.
The Smith & Nephew Tandem Bipolar Hip System is designed for use in partial hip replacement (hemiarthroplasty), in which only the femoral head and neck is replaced. It is indicated for use in patients suffering from:
Smith & Nephew received clearance for the Tandem Bipolar Hip System via the U.S. Food & Drug Administration’s (FDA) 510(k) process. This process allows a medical device to come to market without the benefit of human clinical trials so long as a manufacturer can demonstrate that the implant is “substantially equivalent” to another device that has already been approved by the FDA.
In August 2016, Smith & Nephew announced a recall for certain batches of the Tandem Bipolar Hip System, after the company determined that some of the devices were manufactured with a retainer groove that is out-of-specification. According to a Hazard Alert issued by the Australian Therapeutic Goods Administration (TGA), this defect could result in three potential failures:
The first two potential failures would be identified during preparation before the Tandem Bipolar Hip System is implanted. However, detachment of the components after implantation could result in adverse events that require hip revision surgery. Detachment of a Tandem Bipolar Hip would occur within the first few weeks after the initial implant surgery, and would be clearly recognized by the patient. Recipients of this device should contact their doctor if they experience unexpected pain, limited mobility or loss of range-of-motion in relation to the implant.
In November 2016, the FDA designated Smith & Nephew’s action a Class II recall. This is the agency’s second-most serious recall classification, and indicates that a device may cause temporary or medically reversible complications.
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