Smith & Nephew Tandem Bipolar Hip Recall

Certain lots of Smith & Nephew’s Tandem Bipolar Hip System were manufactured with a retainer groove that is out-of-specification. This defect could result in adverse events, including detachment of the hip components just a few weeks after surgery.  The Smith & Nephew Tandem Bipolar Hip recall was announced in August 2016, and was later designated a Class II recall by U.S. health regulators.

Contact a Hip Recall Lawyer Today

The nationwide law firm of Bernstein Liebhard LLP has successfully represented hundreds of people harmed by recalled hip implants. If you or a loved one suffered complications that may be related to this recall, please contact our office at (888) 994-5118 to learn more about filing a Smith & Nephew hip lawsuit.

What Prompted This Smith & Nephew Hip Recall?

The Tandem Bipolar Hip is a partial hip replacement system. In August 2016, Smith & Nephew recalled recalled the devices after determining that certain batches were manufactured with a retainer groove that is out-of-specification. This could lead to improper assembly or a head that cannot move freely due to excessive tightness. These issues would be recognized in the operating room prior to implantation. However, a third failure – device detachment — could result within a few weeks of surgery.  In such cases, affected patients could experience adverse events that necessitate revision surgery to remove and replace the hip.

In November 2016, the Smith & Nephew Tandem Bipolar Hip recall was designated Class II by the U.S. Food & Drug Administration. This classification indicates that the devices may cause temporary or medically reversible complications. More than 5,800 units have been distributed in Australia, Belgium, Canada, China, Cyprus, France, Germany, India, Italy, Japan, Korea, Mexico, Netherlands, Poland, Portugal, Puerto Rico, Singapore, South Africa, Spain, Switzerland, Thailand, Turkey, United Arab Emirates, and the United States.

Victims of Tandem Bipolar Hip detachment will experience obvious symptoms within a few weeks of surgery, including:

  • Unexpected pain
  • Limited mobility
  • Loss of range-of-motion in relation to the implant

Proactive revision is not recommended for individuals whose hip is functioning normally, as the overall risk of device detachment is low.

Learn More about Filing a Smith & Nephew Hip Recall Claim

Bernstein Liebhard LLP is offering free, no-obligation legal reviews to patients who suffered device detachment related to the Smith & Nephew Tandem Bipolar Hip recall. To learn if you qualify to file a hip replacement lawsuit, please call (888) 994-5118.

  1. Australian TGA (2016) “Hazard alert – potential need for revision surgery due to parts becoming detached” https://www.tga.gov.au/alert/tandem-bipolar-hip-system
  2. FDA (November 2016) “Class 2 Device Recall TANDEM Bipolar Hip System”http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRes/res.cfm?ID=150044
Last Modified: January 27, 2017

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