In May 2011, Stryker
announced the FDA approval for the ShapeMatch Cutting Guide through 510(k)
clearance, an approval shortcut maintained by the US Food and Drug
Administration and allowable when a device is found to be substantially similar
to a previous device and can be marketed safely. The ShapeMatch Cutting Guides
were considered advantageous to standard cutting guides because they were
custom fit for an individual patient and not the one-size-fits-all model that
was previously on the market.
Within 18 months, Stryker
was instructing surgeons to stop using the ShapeMatch Cutting Guide, and to
refrain from ordering any more units of the customized cutting guides. The
company formally recalled the ShapeMatch Cutting Guides in January 2013.
The FDA responded three
months later with a Class I recall of the product. A Class I recall is the most
serious of recalls in the FDA response roster. Class I recalls are reserved for
“a situation in which there is a reasonable probability that the use of or
exposure to a volatile product will cause serious adverse health consequences
or death.”
The ShapeMatch Cutting
Guides were designed to be customized for each patient based on a surgeon’s
pre-surgery planning parameters. Once in place, the guide was designed to
achieve more efficient and precise cutting of bone in order to place the
Triathlon Knee implants.
However, it was found,
potentially due to a software glitch, that the customized cutting guides were
not manufactured to the surgeon’s specifications for the individual patient.
Thus,
the implant could be misaligned, causing Stryker Triathlon Knee implant pain,
and other issues pertaining to mobility and stability, for the patient.
It does not appear that
the problematic ShapeMatch Cutting Guides, designed to work with Stryker’s
Triathlon Knee implant, adversely affects the Triathlon Knee implant
itself. The Triathlon Knee is still on the market and heavily promoted by
Stryker.
The ShapeMatch Cutting
Guides were mostly implemented on the two coasts; concentrated areas include
Pennsylvania.
Pittman, Dutton &
Hellums, P.C., is currently investigating claims against Stryker over their
ShapeMatch Cutting Guides. If you or a love one was adversely affected by Stryker’s
ShapeMatch Cutting Guide,
please contact Booth Samuels at booths@pittmandutton.com or call toll free 1-866-515-8880.
