GB K-MOD Mode D'emploi page 13

K-­‐MOD R EV:
The r evision a rthroprosthesis K -­‐MOD R EV i s i ndicated b oth f or r evision s urgeries a nd f or p rimary t otal k nee
arthroplasty. T he m ain i ndications f or t his t ype o f d evice a re t herefore a s f ollows:
1. Degenerative o r p ost-­‐traumatic o steoarthritis;
2. Failure of first implant prosthesis (for example: infection, instability, lack of fixing in the event of
non-­‐cemented p rosthesis, w ear o f c omponents, m obilization, e tc.);
3. Fracture o r a vascular n ecrosis o f t he k nee j oint;
4. malposition c orrection v arus, v algus o r f lexion;
5. rheumatoid a rthritis.
The femoral components, the tibial tray, the patellar component, and the wedges are available ONLY for
cemented f ixation. T he d iaphyseal s tems a re i ndicated f or c ementless a pplication.
The a nallergic v ersion c haracterized s olely b y a T iNbN c oating s hall b e i mplanted t hrough c ementation.
The fixed-­‐bearing Ultra-­‐Congruent design is indicated in case of Posterior Cruciate Ligament (PCL)
sacrificing, when it's not necessary its substitution, while the CR model provides its preservation. The
Dynamic C ongruence d esign i s i nstead i ndicated b oth i n c ase o f P CL p reservation ( it h as i n f act a s lot f or t he
insertion of the PCL) and in case that it is necessary to remove it. This is due to the particular geometry of
the i nsert w hich g uarantees i ts h igh s tability.
CONTRAINDICATIONS
Both revision and primary total knee arthroplasty surgeries are absolutely contraindicated in case of: local
or s ystemic i nfection, s epsis o r o steomyelitis. I t i s r elatively c ontraindicated i n t he f ollowing c ases:
1. Osteoporosis;
2. Injuries o f t he b one s tructures ( i.e., g iant t umor c ell o r a ny m alignant t umor, b one c ysts, e tc..);
3. Uncooperative p atient o r a p atient w ith n eurologic d isorders, w ho i s u nable t o f ollow i nstructions;
4. Systemic a nd/or m etabolic d isorder w hich l ead a p rogressive d eterioration o f t he b one s upport;
5. Osteomalacia;
6. Distant f oci o f i nfections w hich m ay s pread t o t he i mplant s ite;
7. General W eakened o f t he i mmune s ystem;
8. Vascular i nsufficiency, m uscular a trophy o r n euromuscular d isease.;
9. Incomplete o r d eficient s oft t issue s urrounding t he k nee;
10. Usual a nd e xcessive c onsumption o f a lcohol a nd / o r d rugs;
11. Obesity;
12. Skeletal i mmaturity.
WARNINGS
1. Improper selection, positioning, alignment and fixation of the implant components may result in
unusual s tress c onditions a nd a s ubsequent r eduction i n t he s ervice l ife o f t he p rosthetic i mplant;
2. Malalignment of the components or an inadequate implant can place inordinate forces on the
components w hich m ay c ause e xcessive w ear a nd/or t he f ailure o f t he i mplant;
3. Malalignment or soft tissue imbalance can place inordinate forces on the components, which may
cause e xcessive w ear. I n t his c ase r evision s urgery m ay b e r equired t o p revent c omponent f ailure;
4. Handle products with the utmost care to avoid scratching or damaging the implant, also during
surgery. Improper preoperative or intraoperative implant handling or damage (scratches, dents,
etc.) c an l ead t o c revice c orrosion, f retting, f atigue f racture a nd/or e xcessive w ear. U se c lean g loves
when h andling i mplants;
5. A c omplete c leaning a nd r emoval o f m etallic p articles, b one c ement a s w ell a s a ny s urgical d ebris i s
necessary t o m inimize a rticular s urface w ear;
6. Do n ot u se t he i mplant i f t here i s s ome d amage;
7. DO N OT m odify i mplants;