Operation/Use/Application; Product Description; Structure, Functionality And Performance Characteristics; Materials And Implant Materials Used - KLS Martin group IPS Implants marPOR Mode D'emploi

IPS Implants® marPOR - patient-specific polyethylene implants
Instructions for Use
• Material sensitivity or allergic reactions
• Qualitative and/or quantitative impairment of the hard and/or soft tissue
• Infections
• Wound-healing disorders
• Dislocation of the implant
• Extrusions of the implant
• Contour realignment (Dislocation of the implant can potentially lead to a secondary intervention for
contour realignment)
• Unsatisfying aesthetic appearance
The user is responsible for informing the patient about the possible adverse effects and residual risks.

4 Operation/Use/Application

4.1

Product Description

4.1.1

Structure, Functionality and Performance Characteristics

Patient-specific implants are created based on a detailed individual case planning in coordination with a
qualified user and only for a previously identified patient known by name. Each implant is individually
designed based on the indication and the patient. Please refer to the case-specific product documentation
for detailed information on the structure, functionality and performance characteristics of the patient-
specific implants. In IPS Gate®, the documentation is assigned to the respective case by means of a unique
case number. In IPS Gate®, the user can call up the case-specific product documentation at any time.
The user's written prescription and design approval, which must be available prior to each production and
delivery of a patient-specific implant, refers to this case-specific product documentation (approval
document). With the written approval, the user confirms that he/she has checked, understood and
acknowledged the case-specific product documentation (approval document).
4.1.2

Materials and Implant Materials Used

Material(s)
Polyethylene (PE)
4.1.3

Processing the patient-specific implants

The size and shape of patient-specific implants cannot be adjusted, as these are already adapted to the
patient's anatomy based on the individual case planning and the anatomical needs of the patient stored
therein.
Revision 01
Material specification(s)
Ultra-High Molecular Weight
Polyethylene (UHMWPE)
Standard(s)
ISO 5834,
ASTM F648
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