The Stryker ShapeMatch Cutting Guides System hit the U.S. market in May 2011 after being cleared through the controversial FDA 510(k) premarket approval loophole, which approves devices that are considered ‘substantially equivalent’ to products already on the market.
According to a since removed press release issued by the FDA on April 10, 2013, Stryker issued the ShapeMatch recall due to a software defect that caused wider cutting ranges which may not meet the surgeon’s pre-operative planning parameters entered through the web application. In additional, Stryker determined that another software defect caused the displayed parameters (e.g. depth of resection, angle of cut) to be inconsistent with the cutting guides produced.
These defects have the potential to cause serious health complications in knee replacement recipients including (but not limited to):
FDA recall warns of defects in Stryker knee surgery software that can cause serious problems in total knee replacements
On 04/18/2013 the FDA announced a Class 1 recall of the Stryker Orthopaedics ShapeMatch Cutting Guide, due to defects that can result in serious consequences for patients receiving total knee replacements, including joint instability, fracture, need for revision surgery, chronic pain, and limitations of mobility.
The ShapeMatch Cutting Guide received FDA 510(k) clearance in May 2011 “for use with the company’s Triathlon Total Knee System.” The product has never been granted an FDA approval. The system has only been marketed under the 510(k) “clearance” process.
Stryker removed the ShapeMatch Cutting Guides from the market in November 2012. The company issued a voluntary recall in January 2013. A company press release noted that “these actions were due to the potential that ShapeMatch Cutting Guides may not have been manufactured in accordance with surgeon preoperative planning parameters or may have been manufactured outside of the planning ranges specified in the 510(k) clearance.”
Did you or a loved one suffer side effects from a Stryker Triathlon Knee Replacement that use ShapeMatch technology?
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