GB K-MOD Mode D'emploi page 16

from a full load until adequate fixation and healing have occurred. The patient should not have unrealistic
functional expectations regarding to activities or occupations such as running, lifting weights and walking
for long periods. Excessive, unusual and/or awkward movement and/or activity, trauma, excessive weight
and/or o besity, c ould b e i mplicated w ith p remature f ailure o f t he i mplant.
POSTOPERATIVE P RECAUTION
The p atient s hould b e v isited p eriodically a fter s urgery a nd h e h as t o b e w arned a bout t he l imitations o f t he
postoperative process. The patient has to follow postoperative instructions, including those arising from
follow-­‐up visits, and he has to be aware that a correct rehabilitation is essential for the implant success. In
fact, in restoring all the functions of the joint, collaboration is needed to overcome the pathological state
and, as required by the bio-­‐mechanical specifications, the device must be integrated in such a way as to
facilitate t he n ormal p rocesses o f b one g rowth.
To do this, it's important that the patient returns to a controlled normal activity, through exams and
radiological analysis, in order to manage the loads that can be applied to the joint and to the medical
device.
Except initially, our devices do not create any particular problems for the patient in everyday life. Should
any p roblems a rise, p lease i nform i mmediately t he p atient.
Periodic p ostoperative X -­‐ray t esting i s r ecommended.
POSSIBLE A DVERSE E FFECTS
The possible adverse effects of the K-­‐MOD system are similar to those occurring with any total knee
replacement, b oth r evision a nd p rimary s urgeries, a nd i nclude t he f ollowing:
1. General Complications related to surgical interventions, medications, other instruments used,
blood e tc.
2. Particulate wear debris from metallic and polyethylene components may be present in adjacent
tissue or fluid. It has been reported that wear debris may initiate a cellular response resulting in
osteolysis w hich c an l ead t o t he i mplant l oosening;
3. Early o r l ate p ostoperative i nfection a nd a llergic r eaction;
4. Intraoperative bone fracture may occur, particularly in the presence of poor bone stock vaused by
osteoporosis, b one d efects f rom p revious s urgery, b one r esorption, o r w hile i nserting t he d evice;
5. Loosening, migration or fracture of the implants can occur due to trauma, loss of fixation,
malalignment, m al p osition, b one r esorption, u nusual a nd/or a wkward m ovement a nd/or e xcessive
activity;
6. Periarticular c alcification o r o ssification, w ith o r w ithout i mpediment o f j oint m obility;
7. Inadequate r ange o f m otion d ue t o i mproper s election o r p ositioning o f c omponents;
8. Variation i n t he l eg l ength;
9. Dislocation or subluxation due to: inadeguate fixation, malalignment or mal position, unusual and
or e xcessive m ovement, t rauma, o besity, w eight g ain. M uscle a nd s oft t issue l axity;
10. Fatigue f racture o f a c omponent c an o ccur a s a r esult o f l oss o f f ixation, s trenuous a ctivity, t rauma,
malalignment, o r e xcessive w eight;
11. Corrosion a t t he i nterfaces b etween c omponents;
12. Wear a nd/or d eformation o f a rticulating s urfaces;
13. Varus-­‐valgus d eformity;
14. Patellar t endon r upture a nd l igamentous l axity;
15. Intraoperative o r p ostoperative b one f racture, a nd/or p ostoperative p ain.
16. Hematomas a nd d elayed w ound h ealing;
17. Temporary o r p ermanent n europathies;
18. Venous t hrombosis a nd p ulmonary e mbolism;
19. Cardiovascular d isorders;
20. Occasional a nd p ermanent n erve d ysfunction.