Idiomas disponibles
Idiomas disponibles
6.
Cardiovascular disorders and thromboembolic disease, including venous thrombosis, and
pulmonary embolus, and heart attack.
7.
Tissue reactions, osteolysis, and/or implant loosening caused by metallic corrosion,
allergy or wear debris or loose cement particles.
8.
Myositis ossificans, especially in males with hypertrophic arthritis, limited preoperative
range of motion and/or previous myositis. The incidence of myositis ossificans is
increased with a history of prior surgery and in cases of infection.
Early Postoperative
1.
Hematoma.
2.
Delayed wound healing or wound dehiscence.
3.
Varus-valgus deformity.
4.
Subsidence associated with all poly components.
Late Postoperative
1.
Inadequate range of motion due to improper selection or positioning of components,
impingement and/or periarticular calcification.
2.
Periarticular calcification or ossification, with or without impediment to joint mobility.
3.
Patellar fracture as a result of excess tension or inadvertent intraoperative weakening.
4.
Aggravated problems of the affected limb or contralateral extremity caused by leg length
discrepancy.
The incidence and severity of complications in total knee replacement are usually
greater in revisions than primary operations. Common problems include placement of
incision and lack of bone stock. Increased operative time and increased incidence of infection,
pulmonary embolism and wound hematoma can be expected with revision procedures.
HOW SUPPLIED
Total knee components are individually packaged and supplied STERILE. All metal
components are sterilized using radiation. Polyethylene components may be sterilized with
gas plasma or radiation, as indicated on the outer package label. Remove from the package
using accepted aseptic technique only after the correct size has been determined.
Ultra High Molecular Weight Polyethylene (UHMWPE) tibial and patellar components are
individually packaged and supplied STERILE. Remove from the package using accepted sterile
technique only after the correct size has been determined. Polyethylene components
should not be re-sterilized. FOR POLYETHYLENE COMPONENTS: DO NOT USE IF THE
STERILE PACKAGE APPEARS TO BE DAMAGED.
RE-STERILIZATION (metal components only)
"Opened-but-unused"
•
"Opened-but-unused" is the term used to refer to a sterile, single use medical device whose
packaging has been opened but the device was not used and did not come in contact with
blood, tissue or bodily fluids. Re-sterilization should be considered only where surgery is
in progress and another suitable implant is not available.
In countries where local regulatory requirements permit the re-sterilization of "open but
unused" metal products only, the following parameters have been validated as
providing a sterility assurance level (SAL) 10 -
•
Re-sterilization process:
o
Wrap implant in accordance with local procedures, using standard wrapping
techniques such as those described in the current revision of ANSI/AAMI ST79.
Use an FDA-cleared Sterilization Wrap.
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