Active infection of the knee/hip; old or remote infection. This may
be an absolute or relative contraindication. Every effort should be
undertaken to rule out preoperative infection in a patient with
suspicious symptoms, such as a history of infection, or when there are
signs of local inflammation, abscesses, fever, increased blood
sedimentation rate, evidence of rapid joint destruction, or bone resorption.
Other conditions that will place excessive demands on the joint:
- Charcot’s joints
- Muscle deficiencies
- Multiple joint diseases
- Refusal to modify postoperative
physical activities
- Obesity
Conditions that tend to impose severe loading on the affected
extremity include, but are not limited to, the following:
- Obesity
- Heavy labor
- Active sports
- History of falls
General neurological abnormalities or neurological conditions,
including mental conditions (e.g., mental illness, senility, drug use,
alcoholism) that tend to preempt the patient’s ability or willingness
to follow the surgeon’s postoperative instructions.
Suspected allergic reactions to metals, polyethylene, bone cement.
WARNINGS
This device is for single patient use only. Do not reuse. Do not
alter implant prior to use.
Do not use without bone cement if bone quality is poor or incapable
of providing good initial fixation.
If uncemented, the patient must be limited in activity and avoid
extreme positions that place strain on the prosthesis for a time
period defined by the surgeon.
Prior to closure, the surgical site should be thoroughly cleansed of
bone chips, bone cement, and any other debris.
Foreign particles at the articular interface may cause excessive wear.
Do not:
- Use this product for other than labeled indications (off-label
use)
- Use any component if damage is found or caused during
setup or insertion
- Use components from other knee systems
(and vice versa) unless expressly labeled for such use. Premature
wear or loosening may develop and may require surgical
explantation.
- Use the Tibial Revision Stem Adapter in femoral
applications. It should be used only with the MOST Options
Proximal Tibial Component (with or without segments).
- Impact the stem into the femoral canal after head component is
assembled. Further impaction could damage the head or the Stem
Adapter.
- Use the Zimmer VerSys® Hip
System +10.5 Co-Cr-Mo Alloy head with the MOST Options
System
- Use only the stem collet screw provided with the
Hinged Femur, Hinged Tibia, and Tibial Revision Stem Adapter
- The stem collet screw has a special self-capturing feature that
is designed to retain the stem should disassociation occur, and must
be used with these components. No other screw should be used as a
substitute
- Use only Zimmer Revision Stems of at least 190 mm
in length with the MOST Options Tibial Revision Stem
Adapter
- Bone screws are available for supplementary fixation
as desired by the operating surgeon. These screws are not approved
for attachment or fixation to the posterior elements (pedicles) of
the cervical, thoracic, or lumbar spine.
- The risk of
implant failure is higher with inaccurate component alignment or
positioning
- Soft tissues should be balanced and components’
positioning should be confirmed
- Fat embolism risk is
increased with intramedullary instrumentation and/or cement
pressurization. Consider venting the femur or tibia