Stryker Knee Lawyers for ShapeMatch Cutting Guide Recall

Harvey Kirk

By Harvey Kirk
Posted October 14, 2013

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The knee replacement lawyers at Saiontz & Kirk, P.A. are reviewing potential claims for individuals who may have received a Stryker Triathlon Total Knee System that was implanted using the Stryker ShapeMatch Cutting Guide, which was recalled due to software issues that caused the guides to not meet the correct specifications for the patient.

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Potentially defective Stryker ShapeMatch Cutting Guides were distributed between May 2011 and November 2012 for use with certain Stryker Triathalon knee replacements.

On April 10, 2013, the FDA announced a Stryker ShapeMatch recall for the single-use, disposable cutting guides, which are intended to be used as to assist the surgeon in correctly placing a Stryker Triathalon total knee replacement during arthroplasty. The guide is used to mark bone before cutting, but it appears that software defects resulted in the production of incorrect cutting guides.

Prior to surgery, doctors provide Stryker with pre-operative planning parameters through a web application, which were specific to the individual patient. However, due to issues with the internal process for planning and producing the ShapeMatch Cutting Guides, many were provided to surgeons that did not meet the approved parameters.

Another software defect may result in displayed parameters for the depth of resection, angle of cut and other parameters not matching the cutting guides produced.

These devices were used with the Stryker Triathlon knee replacement, which could leave artificial knee patients suffering from:

  • Joint Instability
  • Fracture
  • Chronic Pain
  • Limitations of Mobility
  • Need for Revision Surgery

As of April 2013, the FDA was aware of at least 44 reports of Stryker Triathlon knee problems that may have been caused by the ShapeMatch Cutting Guides.

Although Stryker notified surgeons to stop prescribing, planning or performing operations with ShapeMatch Cutting Guides in November 2012, a recall was not issued until April 2013. At that time, the manufacturer recommended that all patients who had a Stryker Triathlon knee replacement surgery in which a ShapeMatch Cutting Guide was used should contact their physicians if they are experiencing any symptoms or problems.

All individuals who received a knee replacement involving the Stryker Triathlon that was implanted with the recalled ShapeMatch Cutting Guide may have important legal rights. The Stryker knee lawyers at Saiontz & Kirk, P.A. are investigating whether financial compensation may be available through a product liability lawsuit.

If you suspect that yourself, a friend or family member may have received a knee replacement where a recalled Stryker ShapeMatch Cutting Guide was used, Request a free consultation and claim evaluation.

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