What is a Stryker ShapeMatch Cutting Guide?
The U.S. Food and Drug Administration approved Stryker ShapeMatch Cutting Guides in May 2011 with a 510(k) market clearance. Stryker ShapeMatch Cutting Guides are used to help in the positioning of total knee replacement during surgery and help guide where to mark the bone before cutting. Manufactured by Stryker Orthopaedics, these cutting guides are single-use and disposable. ShapeMatch Technology uses “patient-specific 3D imaging data” from CT or MRI scans to help customize patient surgical plans before surgery.
Stryker ShapeMatch Cutting Guide Recall
Stryker Orthopaedics asked that surgeons discontinue using and ordering ShapeMatch Cutting Guides in November 2012. It was taken off the market at that time.
In January 2013, Stryker issued a voluntary recall of the product. This didn’t include the Triathlon standard instrumentation or the Triathlon Knee System. Stryker found that ShapeMatch Cutting Guides may not have been manufactured properly, in agreement with the “planning parameters” of surgeons, or may have been “manufactured outside of the planning ranges specified in the 510(k) clearance.”
The 510(k) clearance is given to manufacturers who give the FDA notice of their intentions to market a medical device at least 90 days in advance. During this time, the FDA decides whether or not there is a similar device already placed into one of three classification categories.
In April 2013, the FDA reviewed and classified Stryker’s voluntary recall of its product as a Class I recall. A Class I recall is considered the most serious recall and there is “a reasonable probability” that if you use this product you will suffer from serious adverse health consequences or death.
These may include one of the following:
- Joint instability
- Chronic pain
- Need for corrective surgery
- Mobility limitations
Before the ShapeMatch Cutting Guide Recall, the FDA had received 44 reports of incidents related to this product. 41 of these were malfunctions and 3 were reported as medically reversible injuries.
If you have not experienced any adverse effects after undergoing surgery involving a ShapeMatch Cutting Guide you should continue to follow-up with your doctor.
Stryker ShapeMatch Cutting Guide Lawsuit
If your surgeon used a Stryker ShapeMatch Cutting Guide during your knee replacement surgery and you experienced or are currently experiencing complications you may be eligible for a ShapeMatch Cutting Guide lawsuit.
Patients have complained of issues involving severe pain and limited mobility following surgery. The ShapeMatch Cutting Guides sometimes led to the knee being positioned incorrectly. This may lead to corrective surgery for patients.
Patients who have undergone this type of knee-replacement surgery and experienced any serious side effects should seek the advice of a ShapeMatch Cutting Guide lawyer. You may be entitled to compensation. Call now for a free consultation.