Limacorporate Discovery Elbow Mode D'emploi page 6

nutritional state of the patient, and 4) the patient must have reached full skeletal maturity.
Implants are single use devices; do not re-use implants that were previously implanted in another
patient. Do not re-use an implant that has previously come into contact with the body fluid or tissue
of another person. After use, the device may be a potential biohazard. Reuse of devices labeled for single-
use may result in product contamination, patient infection and/or failure of the device to perform as intended.
Surgical instruments are subject to wear with normal usage. After extensive use or excessive loads,
instruments are susceptible to fracture. Surgical instruments should be used only for their specific purpose.
Before use, the functionality of surgical instruments should be checked since the use of damaged instruments
may lead to early failure of the implants. Damaged instruments should be replaced before surgery.
3.2. INTRAOPERATIVE
The use of trial devices is recommended to check the correct site preparation, size and positioning of the
implants to be used. It is recommended that additional implants be available during surgery for use in those
cases requiring prostheses of different sizes or when the preoperatively selected prostheses cannot be used.
The correct selection as well as the correct seating/placement of the implant is extremely important. Improper
selection, positioning, align¬ment and fixation of the implant components may result in unusual stress
conditions which may negatively affect system performance and survival rate of the implant. Malalignment
of the components or inaccurate implantation can lead to excessive wear and/or failure of the implant or
procedure. Inadequate preclosure cleaning (removal of surgical debris) can lead to excessive wear. Improper
preoperative or intraoperative implant handling or damage (scratches, dents, etc.) can lead to crevice
corrosion, fretting, fatigue fracture and/or excessive wear. Care is to be taken to assure complete support of
all parts of the device embedded in bone cement to reduce the risk of stress concentrations that may lead to
failure of the procedure. Complete preclosure cleaning and removal of bone cement debris, metallic debris
and other surgical debris at the implant site is critical to minimize wear of the implant articular surfaces. Implant
fracture due to cement failure has been reported.
The components forming original LimaCorporate systems must be assembled according to the surgical
technique and used only for the labeled indications.
Use only instruments and prosthesis trials specifically designed for use with the implants being used. The
use of instruments designed for use with other systems can lead to inappropriate preparation of the implant
site, incorrect positioning, alignment and fixation of the devices followed by loosening of the system, loss of
functionality, reduction of the durability of the implant, and the need for further surgery.
Care must be taken to protect the surfaces involved in the coupling between components (tapers); articular
surfaces of the implants should be protected from scratches or any other damage. All component coupling
surfaces should be clean and dry before assembly. The stability of component couplings should be verified as
described in the surgical technique. Use clean gloves when handling implants. Laboratory testing indicates
that implants subjected to body fluids, surgical debris or fatty tissues have lower adhesion strength to cement
than implants handled with clean gloves.
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