In the wake of recalls in the US and Australia, litigation is building against Smith & Nephew over its Tandem Bipolar Hip System, which can detach after surgery.
The firm issued a recall on August 29, 2016, to return any stock product. The FDA followed up with a Class 2 device recall for the Tandem Bipolar hip on November 3, 2016, because “some Bipolar shells were manufactured with an out-of-specification retainer groove.”
The Australian Department of Health issued a hazard alert on Sept. 12, warning patients and health professionals that the manufacturing defect, “could lead to three potential failures, including the device not assembling properly and the head being too tight and not moving freely. Both of these failures would be identified during preparation before the implantation surgery.”
“The third potential failure is the device may appear to be assembled properly during the implantation surgery, but parts become detached at a later time. If the third failure occurs, it could result in adverse events and require revision surgery,” it says.
5,000+ units distributed
The device is a partial hip replacement, which is used to replace half of the hip joint (also known as hemiarthroplasty) in which only the femoral head or “ball” of the damaged hip is replaced, according to attorney Michael E. Schmidt of The Schmidt Law Firm of Dallas.
So far 5,806 units were distributed nationwide and in 23 developed nations. Signs of the hip failure include unexpected pain, limited mobility or loss of range-of-motion.
According to attorney Collen A. Clark of The Clark Firm in Dallas, “The surgeon should hear a “click” when the components are assembled properly. If the surgeon implants a device that is not assembled properly, it could detach suddenly. This will probably occur within the first few weeks after the operation.”