Stryker ShapeMatch Cutting Guide Recalled Due to Misalignment Concerns

Mahway, NJWhen patients anticipate hip and knee replacement failures, they generally think the problem will be with the implant itself. Many people do not consider that there might be an issue with the technology that is supposed to make the implant surgeries easier. But concerns about the Stryker ShapeMatch Cutting Guide suggest that while there can be issues with implanted devices themselves, there can also be problems with technology used during the surgeries.

The ShapeMatch Cutting Guide is used for knee replacement surgery to create a cutting guide prior to the surgery that the surgeon can then use during the actual replacement procedure to help position components properly in the patient’s knee. The benefits of using the cutting guide are that they are customized to each patient’s specific anatomy and allow the surgeon to make smaller cuts to the bone during the surgery. Smaller incisions and customized implant placement have obvious benefits for the patient.

Concerns have been raised about the ShapeMatch, however, including that the device can be misaligned, resulting in implants being improperly placed in the patient’s knee. Improperly placed implants can cause pain, limited mobility, fracture and knee instability. Patients who have an improperly placed knee implant may require revision surgery, to replace the implant.

When a Class 1 Medical Device Recall of the ShapeMatch was announced in April 2013, the FDA noted that it had received 44 reports of issues linked to the ShapeMatch. That followed a November 2012 warning from Stryker Orthopaedics to surgeons to stop performing procedures with the ShapeMatch Cutting Guides.

According to the news release, Stryker recommended patients who had knee replacement surgery that involved the ShapeMatch contact their surgeon if they experience symptoms of issues with their knee implant. Patients who are symptom-free may simply follow up with their surgeon as necessary.

Class 1 recalls are the most serious type of recall and are issued when there is a reasonable expectation that use of the recalled product can result in serious adverse health effects.