If you had total knee replacement surgery (arthroplasty) and suffered from a bad knee implant, instability, fracture, revision surgery, pain, or limited mobility, you may have been injured by the Stryker ShapeMatch Cutting Guide. Recently, a recall was issued because a software defect may cause a poorly-fitted knee implant. The problem has caused at least 44 incidents and injuries.
Do I Have a Texas Stryker ShapeMatch Lawsuit? Collen A. Clark is a true advocate for his clients and is passionate about helping Texans that have been injured or wronged. If you or a loved one was injured by a bad knee replacement caused by a Stryker ShapeMatch Cutting Guide, you should contact our lawyers immediately. You may be entitled to compensation by filing a Stryker ShapeMatch lawsuit in Texas.
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.”
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
- Abnormal sounds (popping, clicking, scraping, etc.)
- Limping or abnormal gait
- Stiffness, loss of flexibility, decreased range of motion
- Infection (swelling, warmth, or redness)
- Nerve damage
- Bone loss
- Need for revision surgery
- Permanent limited mobility, decreased walking ability
Do I have a Stryker ShapeMatch Lawsuit in Texas?
Collen A. Clark is a true advocate for his clients and is passionate about helping Texans that have been injured or wronged.
Collen’s amazing success in the courtroom and well known dedication to his clients has earned him the recognition of his peers as one of The Top Trial Lawyers in Texas.”
The Clark Firm has assembled a team of trial lawyers with more than 100 years experience, participation in over 600 jury trials and $60 million in verdicts and/or settlements. Please use the form below to contact us for a free Texas Stryker ShapeMatch lawsuit review.