Australia’s Therapeutic Goods Administration is warning of the potential need for revision surgery due to parts becoming detached in Smith & Nephew’s Tandem Bipolar Hip System.
The firm discovered that a number of devices were manufactured with a retainer groove that is out-of-specification. The nonconformance 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 other potential failure is parts detaching after implantation surgery, even though the device may appear to be assembled properly during surgery.
If this failure occurs, it could result in adverse events and require additional surgery.
See the affected lot numbers here: www.fdanews.com/09-15-16-TGAalert.pdf. — Tamra Sami