GB K-MOD Mode D'emploi page 14

8. The K-­‐MOD components are DISPOSABLE so it's not allowed their reuse. The repeated use leads to
a s ystem b urdened b y a p revious u se, w hich i mpairs t he f atigue s trength a nd t hus i ncreases t he r isk
of r upture;
9. Do n ot t reat p atients w ith c omponents w hich h ave b een p laced, e ven i f m omentarily, i n a d ifferent
patient;
10. DO NOT USE a K-­‐MOD prosthetic component with a component manufactured by another
company b ecause c ompatibility i s n ot e nsured;
11. Use A LWAYS t he l ocking s crew i n a ny f ixed-­‐bearing m odel;
12. The l ocking s crew i s n ot c ompatible w ith t he m obile b earing d esign;
13. The l ocking s crew m ust b e i nserted a nd s crewed E SCLUSIVELY a fter t hat t he f ixed m eniscal i nsert i s
hooked o n i ts r elative t ibial t ray;
14. The f emoral c omponent a nd t he i nsert i mplanted w ill h ave t he s ame s ize;
15. There is a complete compatibility between the sizes of the tibial tray and the insert. However it's
recommended t o n ot d iffer i n t he c hoice o f m ore t han o ne s ize.
16. Particular care should be taken to ensure the complete support of all cemented components to
avoid a n o verstressing w hich c ould l ead t o a p rocedure f ailure;
17. It is the responsibility of the operating surgeon to determine whether there is adequate initial
fixation and stability. There are, moreover, for K-­‐MOD Primary, tibial stems if additional stability is
needed.
18. T he posterior-­‐stabilized (PS) femoral components and the posterior-­‐stabilized (PS) inserts should
be c oupled E XCLUSIVELY b etween t hem.
19. T he posterior-­‐stabilized (PS) femoral components should NOT be coupled with the CR, Ultra-­‐
Congruent a nd D ynamic C ongruence i nserts.
20. T he p osterior-­‐stabilized ( PS) i nserts s hould N OT b e c oupled w ith t he s tandard f emoral c omponents
without c entral b ox.
21. In the case of knee arthroplasty K-­‐MOD REV, if the use of femoral/tibial wedge augments will be
necessary A LWAYS u se t he r elevant l ocking s crews;
22. In the case of knee arthroplasty K-­‐MOD REV in case of non-­‐use of the off-­‐set adaptor, ALWAYS use
the locking headless locking screw to secure the diaphyseal stem to the femoral and tibial
components. T he h eadless l ocking s crew m ust b e s crewed O NLY a fter c oupling t he d iaphyseal s tem
to t he c omponent;
23. In the case of knee arthroplasty K-­‐MOD REV, in case of off-­‐set adaptor use, ALWAYS use the
headless locking screws either to fix the diaphyseal stem to the off-­‐set adaptor either to fix the
latter t o t he f emoral a nd/or t ibial c omponents. T he h eadless l ocking s crews m ust b e s crewed O NLY
after c oupling t he s tem t o t he o ff-­‐set a daptor a nd t he o ff-­‐set a daptor t o t he c omponent;
24. In t he c ase o f k nee a rthroplasty K -­‐MOD R EV p osition t he c ement u ntil t he c onnection b etween t he
diaphyseal stem and the component or, in the case of off-­‐set adaptor use, until the connection
between t he d iaphyseal s tem a nd t he o ff-­‐set a daptor;
25. Patient s moking m ay r esult i n a d elayed h ealing, n on-­‐healing a nd/or c ompromised s tability;
26. It is the responsibility of the operating surgeon to ensure that patient is not sensitive to the
materials u sed t o m anufacture t he i mplant's c omponents.
27. The surgeons and other users need to be aware that, if explanted, the retrieved devices must be
treated as contaminated and contaminating products and that they need to be disposed according
to t he a pplicable p rocedures a vailable a t t he h ospital.
28. The devices manufactured by Gruppo Bioimpianti have not been evaluated for safety and
compatibility in the MR environment. They have not been tested for heating, migration, or image
artefact in the MR environment. Their safety in the MR environment is unknown. Scanning a
patient w ho h as s uch d evices m ay r esult i n p atient i njury.
The K-­‐MOD system provides the surgeons, both in case of revision or primary total knee arthroplasty
surgeries, the necessary instruments to reduce pain and restore the knee joint function. While these
products a re g enerally s uccessful i n a ttaining t hese g oals, t hey c annot b e e xpected t o w ithstand t he a ctivity
levels a nd f unction o f a n ormal h ealthy j oint.