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Stryker ShapeMatch Cutting Guide Triathlon Knee Implant Injury

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Stryker, maker of the ShapeMatch Cutting Guide faces a defective product lawsuit regarding its ShapeMatch device. The Stryker ShapeMatch is used as part of the Stryker Custom Fit knee implant to assist with knee replacement surgery, but has reportedly caused injury to the patient, according to a defective product claim. The Stryker ShapeMatch was the subject of a Class I Urgent Medical Device Recall on April 10, 2013.

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MRI before Stryker Knee Replacement

zimmerkneepostop Before a patient has Stryker Custom Fit knee replacement surgery utilizing the Stryker ShapeMatch cutting guide, an MRI scan will be done in order to create a 3D image of the patient's knee. Once the 3D image is created, cutting guides are made according to that 3D model of the knee; the cutting guides are then used during the actual knee replacement procedure in order to help the surgeon position the knee components.

If you have had an MRI before knee replacement surgery--in order to create a 3D model of your knee from which cutting guides will be made--your surgeon may have used the Stryker Custom Fit Knee System and Stryker ShapeMatch Cutting Guides. If you were unable to have an MRI, you may have had a 3D knee replacement model created using a CT scan.

Stryker ShapeMatch Cutting Guide Problems

The Stryker ShapeMatch Cutting Guide is a surgical device used during total knee replacement surgery to position the knee replacement components and guide bone marking before the bone is cut. According to the US FDA, ShapeMatch Cutting Guides are single-use guides used with the Triathlon Knee System.

The ShapeMatch Cutting Guide was designed to allow surgeons to make smaller incisions in the patient's knee and to customize the surgery to the patient's anatomy. The patient undergoes an MRI of the knee prior to surgery and software is then used to create a three-dimensional knee model. That 3D knee model is used to determine the size and position of the knee implant, and ShapeMatch technology is then used to create customized guides to aid the surgeon in cutting bone and positioning the implant.

A defective product complaint concerning the Stryker ShapeMatch, however, alleges the device was misaligned, which resulted in the knee implant being placed in the wrong position. Issues with the Stryker ShapeMatch Cutting Guide reportedly include displayed parameters on the software not matching the cutting guides that were produced and cutting guide parameters not meeting pre-operative planning parameters for surgery. These issues can result in joint instability, pain, limited mobility and fractures, and may require revision surgery.

Stryker ShapeMatch Recall


On April 10, 2013, Stryker issued a Class I Urgent Medical Device Recall regarding the Stryker ShapeMatch. The company recommended that patients who had knee replacement surgery that involved the ShapeMatch contact their surgeon if they experienced symptoms of problems in their knee.

When it announced the recall, the FDA noted that it had received a total of 44 reports—including 41 malfunctions and three temporary, medically reversible injuries—of incidents linked to the ShapeMatch.

In November 2012, Stryker Orthopaedics e-mailed medical professionals about issues with the cutting guides and informed those professionals that they should stop using the cutting guides until further notice. The Stryker Triathlon Knee System is not subject to the recall.



Stryker Shapematch Cutting Guide Legal Help

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STRYKER SHAPEMATCH LEGAL ARTICLES AND INTERVIEWS

Lawsuits Allege Plaintiffs Harmed by Stryker ShapeMatch
Lawsuits Allege Plaintiffs Harmed by Stryker ShapeMatch
April 18, 2014
New Orleans, LAStryker ShapeMatch lawsuits have been filed against Howmedica Osteonics Corp (doing business as Stryker Orthopaedics), alleging patients were harmed by the use of the ShapeMatch Cutting Guide. The plaintiffs allege that issues with the ShapeMatch Cutting Guide, used with the Stryker Triathlon knee implant, resulted in knee implant failure.
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ShapeMatch Cutting Guide Lawsuit(s) a Non-Issue in Stryker’s Q4
ShapeMatch Cutting Guide Lawsuit(s) a Non-Issue in Stryker’s Q4
March 30, 2014
Kalamazoo, MI When Stryker did an about-face on its troubled ShapeMatch Cutting Guide in November 2012 after only 18 months, the medical device company said at the time that patients who had undergone knee replacement utilizing the recalled guides would not require follow-up “beyond the routine standard of care.” However, plaintiffs having filed a ShapeMatch Cutting Guide lawsuit, beg to disagree with that statement.
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Stryker ShapeMatch Lawsuit Survives Motion to Dismiss
Stryker ShapeMatch Lawsuit Survives Motion to Dismiss
March 8, 2014
Lafayette, LA A Stryker ShapeMatch lawsuit has survived a motion to dismiss by the defendants, although the plaintiff has been told she must amend her complaint. The ShapeMatch Cutting Guide lawsuit alleged the plaintiff was harmed by the use of the cutting guide, which was recalled since her surgery.
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READER COMMENTS

Posted by

on
this is about the total knee replacement and bair hugger claim that happened in ST Vincent hospital Indianapolis Indiana on July 25th 2011. I had to have a revision surgery and a antibiotic spacer put in and I spent 6 months in ST Vincent hospital Indianapolis Indiana. I had a severe blood infections and metal poisoning and my doctor would not test me for an infection that's neglect!! Then I was told that I will never walk again and I have been on crutches every since the knee replacement!! I lost all the muscles in my leg I'm in so much pain I can't sleep can't hardly do anything! when this happend to me it coast me my marriage and I have 2 Kids that I can't hardly do anything with they told me the only thing they can do is amputation!! they took my life from me!!

Posted by

on
Knee replacement 12-09-2015. 8monthslater woke up at 4.0 am went walk ontheKnee replacement Sttracker hard moveing my knee , always in pain pain will not take the edge offf . Etc.. very hard todomy work and walketc.. walk Quilty of life . Knee surgey June 19 2017

Posted by

on
I had a knee replacement a few years ago and I have had nothing but problems and pain, weakness ,buckling, and a revision 6 mo. ago that has made my knee worse. I would like to talk to someone about this.

Thank you,

Mike

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