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Published: October 1st, 2013
A recall has been issued for Stryker ShapeMatch Cutting Guides, which were used with Stryker Triathlon knee replacements to help surgeons plan out and mark bones before surgery. A number of former knee replacement patients have experienced problems where their implant was misaligned due to the defective cutting guides.
STRYKER KNEE REPLACEMENT LAWSUIT STATUS Product liability lawyers are reviewing potential Stryker ShapeMatch recall lawsuits for individuals who have experienced problems following surgery where a Stryker Triathalon knee replacement was used, such as:
- Pain and Discomfort
- Joint Instability
- Limited Mobility
- Revision Surgery to Remove and Replace the Artificial Knee
OVERVIEW: The Stryker ShapeMatch Cutting Guide was sold with the company’s Triathalon Total Knee System to assist in the placement and marking of bone before cutting.
The single-use, disposable guides are created from plans submitted by the surgeon after taking 3D imaging from an MRI or CT scan to determine the appropriate placements for a specific patient. The surgeon creates the plans, submits them through a web app and reviews the information before approval. However, due to problems with the Stryker ShapeMatch software, many of the cutting guides provided by the manufacturer did not match the appropriate specifications.
As a result of using a defective ShapeMatch Cutting Guide, patients could experience problems with their Stryker Triathlon knee replacement that result in severe pain, joint instability and the need for revision surgery to remove or replace the misaligned knee implant.
STRYKER KNEE RECALL Stryker stopped selling the ShapeMatch Cutting Guide in November 2012. A Product Notification was sent to all hospitals and medical providers using the system in January 2013, informing them of the problem and risk mitigation factors.
It appears that the FDA was not informed of the Stryker knee problems or of the many complaints received by the manufacturer. The FDA issued a warning letter to Stryker in March, claiming that the company had failed to notify the agency of a medical device recall, but the letter did not mention the ShapeMatch Cutting Guides by name.
In April 2013, a Stryker ShapeMatch Cutting Guide recall was issued and categorized by the FDA as a Class I recall, because of the substantial likelihood for serious injury. At that time, the FDA had received a total of 44 reports of ShapeMatch Cutting Guide problems, including 41 malfunctions and three injuries.
According to allegations raised in Stryker knee replacement lawsuits filed over the ShapeMatch recall, the manufacturer:
- Failed to properly report problems with the Stryker Triathalon knee replacement
- Failed to conduct an investigation and analysis of the knee replacement failures
- Failed to report any and all information regarding corrections
- Failed to adequately warn surgeons and hospitals about the risk of problems
- Failed to conduct necessary design validation
As a result of problems following Stryker knee replacement surgery, product liability lawyers are reviewing potential claims nationwide. Financial compensation may be available through a Stryker ShapeMatch recall lawsuit as a result of the manufacturers actions, in which they appear to have placed their desire for profits before patient safety.