Intraoperative Procedure - KLS Martin group IPS Implants marPOR Mode D'emploi

IPS Implants® marPOR - patient-specific polyethylene implants
Instructions for Use
4.3

Intraoperative procedure

Possible risk to patient life due to contamination of the implant during handling!
Contamination of the implant with microorganisms and foreign material due to the large surface of
porous implants can cause infections.
• Prepare the implantation location before the implant is removed from the sterile packaging and
shaped.
• Implant the implant immediately after removing it from its sterile packaging, or place it in a clean
container with sterile saline.
Do not place implants on operating cloths, operating clothes or other surfaces that could lead to
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contamination.
Possible risk to patient life due to implant loosening caused by incorrect positioning!
Cover implants with periosteum or other soft tissue structures.
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Possible risk of injury to the patient due to improper handling!
• Improper handling of the patient-specific implant can result in implant failure and injuries.
Damage reduces the load-bearing capacity and may lead to breakage of the implant.
•
Possible risk of injury to the patient due to fragment formation!
Should the patient-specific implant break during surgery, all fragments must be removed from the
•
situs. Otherwise, there is a risk of foreign body reactions or migration with resulting soft tissue
damage.
Patient-specific implants are created based on an individual case planning process in coordination with a
qualified user and exclusively for a previously identified patient known by name. The products are
individually designed based on the indication and the patient. Please refer to the case-specific product
documentation for detailed information on the attachment of the patient-specific implants. In IPS Gate®,
the documentation is assigned to the respective case.
The case-specific product documentation includes the preoperative situation, the planned positioning of
the implants, and the planned postoperative situation. Depending on the respective indication, the case-
specific product documentation may include further information on the intraoperative procedure.
Revision 01 25