I showed the surgeon the implant boxes, who confirmed
they were the correct ones. The boxes were then opened and handed
to the scrub nurse. Shortly after the cement had set, the knee in
question didn’t look right. It was a right implant in a left
knee. Informed surgeon that the implant was wrong. Surgeon
attempted to remove the femoral component and a small piece of
the femoral condyle came away that was cemented to the femoral
component. At this point, three other surgeons scrubbed to
assist. They proceeded to remove the femoral component and then
repaired the left lateral condyle which had broken off. Once the
condyle was repaired, it was decided that a total stabilizer
femoral component normally used for revisions of prior knee
replacements would be required.
Patient was scheduled and consented for a left total knee
arthroplasty. A right femoral component was placed instead of the
correct left femoral component. This was discovered on x-ray in
PACU. Patient was allowed to wake up and physician discussed
risks and benefits of leaving the left component in place or
returning to surgery to have the right-side component placed. The
patient elected to return to surgery and have the implant
replaced. The patient recovered well from the two procedures and
discharged home the following day.
Bilateral case. The left knee was opened first. The scrub
tech opened the right implants instead of the left implants. The
nurse and surgeon both inspected the right implants and implanted
them. While the left knee was beginning to be closed, the nurse
looked at the implant ticket and noticed that the right implants
were put in instead of the left. The surgeon immediately
explanted the right implants and implanted the left implants and
closed the knee. He then implanted a new set of right implants in
the right knee without a problem. This added 1 hour to the
Knee replacements pose a significant risk of wrong-sided implant
use. Many CHPSO members reported experiencing near misses. And,
several times, a wrong-sided component was implanted. Review of
the FDA MAUDE device event reporting database shows even more
cases, and the case summaries above were selected from there.
Insertion of the wrong medical implant into the correct surgical
site is a serious reportable event according the National Quality
Forum: Wrong surgical or other invasive procedure performed
on a patient.
CHPSO’s analysis identified several factors leading to the
increased risk, including:
Hospitals have protocols in place for confirming procedure
sidedness before starting the procedure. Picking the correct
implant to use in the case may happen much later.
Hip components are typically bilateral without need to
identify sidedness, while many knee components are sided.
Procedures that work well for confirming proper hip components
are not sufficient for knee components.
Operating room personnel may not always follow a standardized
process for knee implant verification.
Knee components that are sided are often subtly asymmetric,
and may not appear obviously wrong when inserted incorrectly.
Package labeling for side is not standardized, may be remote
from the size label and may not be as prominently displayed.
Sizing is a key step in the procedure and much attention is
paid to proper size as opposed to proper side, drawing attention
away from the sidedness labeling.
Several people including supplier representatives may move
stock around. Unless well-controlled, this could lead to devices
being in unexpected locations.
Bilateral procedures are not uncommon. Devices for both
sides may be present in the OR simultaneously and there are
multiple times during bilateral procedures at which sidedness
errors can occur.
Hospitals have diverse ways of managing stock, OR staffing,
vendor representatives and OR processes. Consequently, the
following recommendations need to be evaluated in the local
context for applicability.
Review the standard processes for implant verification and
confirm that standard processes are uniformly followed.
Review how component stock is managed, including who can
move, remove and replace items. Standardize how separation by
laterality is managed.
Identify a proper point in the procedure to definitively
verify sidedness of the components. Some organizations may do
this during the initial time out by verifying that the only
components in the room are for the correct side; not allowing in
any other components without a repeat time out. Others may
implement this at the time of implant sizing and specific
Review how vendor representatives are involved in picking the
correct component box.
Consider providing memory aids (e.g., pictures) pointing out
the locations of the size and side information on the range of
devices used in that facility, and showing which devices are
sided and which are bilateral.
If you have documents, e.g., policies or safety alerts, that you
wish to share on this topic, please contact Rory Jaffe at
916-552-2600 or firstname.lastname@example.org. We can deidentify the
documents if you prefer.