Stryker Orthopedics recalled the ShapeMatch Cutting Guide after 44 reports of inaccurate bone cuts. The problem could result in a poorly-fitted knee implant, resulting in chronic pain, instability, knee fracture, disability, and revision surgery.
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.
44 Injuries Prompt Stryker ShapeMatch Recall
On April 18, 2013, Stryker Orthopedics and the U.S. Food and Drug Administration (FDA) announced an urgent Class 1 recall of the Stryker ShapeMatch Cutting Guides. This product was used in surgery with the Triathlon Total Knee System from May 2011 until November 2012, during which time it caused at least 44 injuries.
“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
The Stryker ShapeMatch Cutting Guide is a system used during the pre-operative planning phase of total knee replacement surgery (arthroplasty). The patient undergoes an MRI (magnetic resonance imaging), which creates a 3D image of the knee. Then, computer software in the ShapeMatch Cutting Guide helps a surgeon choose the correct size, positioning, and alignment of the Triathlon Total Knee System.
What is the problem?
Stryker first warned about software problems with the ShapeMatch Cutting Guide in an e-mail sent in November 2012, in which they warned customers not to use the product until further notice. In January 2013, Stryker sent a Product Notification to inform hospitals, surgeons, and others about risk mitigation strategies.
Stryker Recalls ShapeMatch
The Stryker ShapeMatch recall was not announced publicly until April 10, 2013, when Stryker issued an Urgent Medical Device Recall notification. By the time the FDA published a recall on April 18, there were at least 44 incident reports — including 44 malfunctions and 3 “reversible” injuries. Stryker advises patients to contact their surgeon if they are experiencing symptoms of a defective knee replacement.
ShapeMatch Injuries & Complications
Stryker ShapeMatch injuries are caused when the knee implant is poorly-fitted to a patient. This can cause premature loosening of the knee, which may require revision surgery. Although some loosening is normal after about three years, a bad knee implant can loosen less than a year after surgery.
Symptoms of Knee Implant Failure
- Misalignment of components
- Knee pain that may grow worse
- Knee instability or looseness
- Abnormal sounds in the knee (clicking, popping, grinding, etc.)
- Knee stiffness, poor flexibility, decreased range of motion
- Bone fracture
- Infection (may cause swelling, warmth, or redness)
- Nerve damage
- Need for revision surgery
- Permanent decreased mobility