Zimmer Biomet StageOn Series User manual

StageOne™Knee Cement
Spacer Molds
Surgical Technique

Figure 1: Internal depth gauge allows
surgeon to customize thickness of tibial spacer.
Figure 2: Articulating spacer
supports patient range of motion.
Description/Indications
The disposable cement spacer molds (femoral and
tibial) are sterile disposables made of medical grade
silicone. They are intended to be filled with PALACOS®
R+G Bone Cement* or Refobacin®Bone Cement R*,
either by injecting with a dispenser/gun, or by pouring
the prepared cement into the mold. After the cement
cures, the temporary spacers are to be removed from
the molds and placed into the joint space. The spacers
remain in place (180 days or less) until the second
stage of the two-stage procedure is performed to
implant a conventional knee joint prosthesis.
Disposable cement spacer molds are indicated for
use to mold a temporary total knee replacement
(TKR) for skeletally mature patients undergoing a
two-stage procedure due to a septic process. The
molded temporary knee prosthesis is indicated for
an implantation period of 180 days or less. Because
of inherent mechanical limitations of the device
material (PALACOS R+G Bone Cement and Refobacin
Bone Cement R*), the molded temporary prosthesis
is only indicated for patients who will consistently
use traditional mobility assist devices (e.g. crutches,
walkers) throughout the implant period.

3 | StageOne Knee Cement Spacer Molds Surgical Technique
Figure 3 Figure 4
Tibial Technique
Select tibial mold size by using available x-ray template.
Inject cement into mold (Figure 3). Use the depth
gauge to determine thickness of the tibial component.
After cement has cured, invert the tibial mold and flex
gently to remove spacer (Figure 4).

4 | StageOne Knee Cement Spacer Molds Surgical Technique
Figure 5 Figure 6
Femoral Technique
Select femoral mold size by using available X-ray
templates. To fill the femoral mold, place the cement
delivery nozzle tightly against the fill port on the side
of the mold and inject the cement (Figure 5). Fill mold
completely without pressurizing the full mold.
As filling nears completion, tip the mold so that the two
small vents nearest the filling port are directed upward
so that all air can escape as filling is completed.
Upon completion of filling, examine the side walls
of the femoral mold for distortion (Figure 6). Over-
filling the mold will result in a malformed spacer.
If necessary, squeeze mold so that excess cement
exits the fill port.
Two to three minutes after filling, observe the
level of cement in the femoral mold at the filling port.
If the level has dropped, inject additional cement
to compensate for the pre-cure shrinkage.

5 | StageOne Knee Cement Spacer Molds Surgical Technique
Figure 7 Figure 8
Femoral Technique (cont.)
After cement has cured, remove femoral spacer from
mold by peeling the mold away from the spacer
(Figure 7).
Trim the spacer with a knife or burr to remove residual
cement (Figure 8).

6 | StageOne Knee Cement Spacer Molds Surgical Technique
Implantation Instructions
Clean infected area using pulse lavage and thoroughly
remove all residual cement remaining from primary
implant before implanting cement spacer.
Spacers should be fixed to bone using the identical
bone cement used to form the spacers (i.e. PALACOS
R+G Bone Cement or Refobacin Bone Cement R).
Cement should stabilize the spacers but deep cement
penetration into bone should be avoided to facilitate
spacer removal at the 2nd stage revision.
Thoroughly remove all excess bone cement around
spacers. Before cement has cured, run leg through
flexion and extension allowing femoral component to
properly center tibial component.
Note: Failure to thoroughly clean joint space of all
cement wear debris may result in loosening and
failure of the 2nd stage revision arthroplasty.

Knee Cement Spacer Molds
Femoral Sizing
75 mm
70 mm
65 mm
60 mm
*Sizes not to scale
Tibial Sizing
80 mm
75 mm
70 mm
65 mm
Cruciate Sacrificing Universal AGC-Style Components
Tibial and femoral sizes are completely
interchangeable.
Catalog No. Femoral Mold Size
Recommended Number
Cement Single Mixes (40G)
432160 60 mm 2
432165 65 mm 2
432170 70 mm 2
432175 75 mm 2
Catalog No. Tibial Mold Size
Recommended Number
Cement Single Mixes (40G)
433165 65 mm 2
433170 70 mm 2
433175 75 mm 2
433180 80 mm 2

Responsible Manufacturer
Biomet Orthopedics
P.O. Box 587
56 E. Bell Drive
Warsaw, Indiana 46581-0587
USA
www.zimmerbiomet.com
0440.1-US-en-REV0116
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