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Smith & Nephew Tandem Bipolar Hip

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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.

Smith & Nephew Tandem Bipolar Hip FDA Clearance

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:

• Non-inflammatory degenerative joint disease such as osteoarthritis;
• Rheumatoid arthritis;
• Arthritis secondary to a variety of diseases and anomalies;
• Correction of functional deformity such as congenital hip dysplasia or ankylosing spondylitis
• Revision procedures where other treatments have failed;
• Treatment of proximal femoral non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement.

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.

Class II Recall for Tandem Bipolar Hip System

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:

• Failure of the device to assemble properly
• Head being too tight and not moving freely
• Detachment of the components after surgery

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.