UPDATE: OtisMed Guilty of Selling Unapproved Knee Implant Cutting Guides

December 11, 2014 — The FDA has announced that the former CEO of OtisMed Corp. has been convicted of criminal charges involving the distribution of unapproved orthopedic cutting guides for Strkyer knee replacements in 2009. Click here to read more.

Stryker ShapeMatch Recalled After 44 Injuries

April 18, 2013 — The U.S. Food and Drug Administration (FDA) and Stryker Orthopedics are announcing a Class 1 recall of the Stryker ShapeMatch Cutting Guides, which were used exclusively with the Stryker Triathlon Knee System. Patients who had knee replacement surgery between May 2011 and November 2012 may have been injured by this device.

FDA warning for Stryker knee replacement:

“FDA notified healthcare professionals of a Class 1 recall for this product due to a software defect that results in wider cutting ranges. The parameters of the manufactured cutting guides may not meet the surgeon’s pre-operative planning parameters entered via the web application. Additionally, Stryker Orthopaedics determined that another software defect resulted in the displayed parameters (e.g. depth of resection, angle of cut) not matching the cutting guides produced. This may result in serious adverse health consequences including joint instability, fracture, need for revision surgery and chronic pain and limitations of mobility.”

Click here to read the official Stryker ShapeMatch recall notice.

Stryker ShapeMatch Cutting Guide for Knee Replacement Surgery

The Stryker ShapeMatch Cutting Guides are intended for use for the Triathlon Total Knee System. The technology is used in pre-operative planning and during surgery to help a surgeon choose the best size, positioning, and alignment for a knee implant.

Patients undergo an MRI (magnetic resonance imaging) scan, which creates a 3D model of their knee. Then, computer technology in the ShapeMatch Cutting Guide helps a surgeon select components that will best fit the patient. Stryker claims the precise cutting guide helps a surgeon to make smaller incisions, place the implant more accurately, and close the incision more quickly.

Knee Problems with the Stryker ShapeMatch Cutting Guide

Stryker Orthopedics identified the issue with the Stryker ShapeMatch Cutting Guides in November 2012 and sent an e-mail to warn their customers to stop using the products due to a software problem. In January 2013, Stryker sent a Product Notification to surgeons and hospitals to inform them about the problem and risk mitigation factors.

Although Stryker ceased marketing and distributing the ShapeMatch Cutting Guides in November 2012, they did not warn patients or issue an Urgent Medical Device Recall until April 10, 2013. By that time, the FDA had received 44 reports of patient injuries, including 41 malfunctions and 3 “reversible” injuries related to the ShapeMatch Cutting Guides.

Stryker now recommends that patients who had knee replacement surgery in which a ShapeMatch Cutting Guide was used should contact their surgeon if they are experiencing symptoms of a poorly-fitted knee implant.

Complications of Stryker ShapeMatch Knee Replacement Injuries

The most likely Stryker ShapeMatch injury is loosening of the knee joint, which is a symptom of a poorly-fitted knee replacement. All knee implants get looser over time, but it is not supposed to occur for at least three years. When a bad knee implant fails prematurely, loosening can occur in less than a year after surgery.

Stryker ShapeMatch knee replacement injuries and complications:

  • Component misalignment
  • Chronic pain, which may grow worse over time
  • Joint instability
  • Loose knee joint
  • Dislocation
  • Abnormal sounds (popping, clicking, scraping, etc.)
  • Limping or abnormal gait
  • Stiffness, loss of flexibility, decreased range of motion
  • Fracture
  • Infection (swelling, warmth, or redness)
  • Nerve damage
  • Bone loss
  • Need for revision surgery
  • Permanent limited mobility, decreased walking ability
  • Disability


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