GB K-MOD Mode D'emploi page 12

STERILIZATION
Product is supplied sterile (according to the definition reported on the standard UNI EN 556). In particular
metal components are sterilized through rays (Beta or Gamma) according to the normative UNI EN ISO
11137-­‐1;-­‐2;-­‐3 while the elements manufactured in polyethylene are sterilized with ethylene oxide (ETO)
according the normative UNI EN ISO 11135-­‐1. Both sterilizations are guaranteed for 10 years. The
sterilization method is indicated on the label in which is also reported the expiry date that indicates the
maximum time to use the product. The packaging (double pack) allows products to be handled by non-­‐
sterile personnel during conservation. The extraction of the product must be carried out by sterile
operating personnel. If at any time during unpacking an anomalous situation arises, it is advisable not to
use the piece because there is a risk that it may have lost the sterility and its return to Gruppo Bioimpianti
which w ill c arry o ut, i f i t i s p ossible, a r econditioning.
IDENTIFICATION A ND T RACEABILITY
All products manufactured by Gruppo Bioimpianti s.r.l. are identified by the label on the packaging which
states the contents, size or another parameter which indicates the dimensions, the product's code, the
production batch, the sterility symbol with the expiration date and the sterilization method. To guarantee
external t raceability e ven a fter i mplantation t hey a re p rovided a s eries o f l abels i nside t he p ackaging, w hich
shall b e u sed o n t he s urgery r egister a nd o n t he p atients' m edical r ecords.
PRESERVATION
Our devices should be kept in hygienically controlled surroundings. The packaging system, however,
guarantees the necessary protection against scratches, damages or loss of sterility of the product during
routine handling. The handling and the preserving of the product have to be in order to not damage the
packaging: If damage should occur, the product should be returned, after due consideration, to Gruppo
Bioimpianti S.r.l. for any necessary re-­‐processing or elimination. Do not use the product if the packaging is
opened o r d amaged o r i n c ase t he e xpiry d ate i s p assed.
INDICATIONS
K-­‐MOD:
The modular knee arthroprosthesis K-­‐MOD is intended for primary total knee replacement. The main
indications t o t he r eplacement o f t he k nee j oint a re t he f ollowing:
1. Joint d iseases ( as f or e xample o steoarthritis, r heumatoid a rthritis, p ost-­‐traumatic a rthritis..);
2. Functional d eformities: v arus/valgus k nee o r p ost-­‐traumatic d eformity;
3. Correction o r r evision o f f ailed o steotomy, a rthrodesis.
The femoral components and the tibial trays which don't present a porous coating, together with the
patellar c omponent, a re E XCLUSIVELY i ndicated f or a c emented a pplication. T he m etal c omponents r ealized
with t he p orous c oating a re i ndicated f or a 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. T he
anallergic uncemented version, instead, characterized both by a TiNbN and a porous coating, is indicated
for c ementless a pplication.
The fixed-­‐bearing Ultra Congruent design, the PS design (both in the mobile and fixed bearing version) and
the mobile bearing APS design are 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 Congruence
fixed b earing a nd t he U ltra C ongruent m obile b earing a re i nstead i ndicated b oth i n c ase o f P CL p reservation
(it has in fact a slot for the insertion of the PCL) and in case that it is necessary to remove it. This is due to
the p articular g eometry o f t he i nsert w hich g uarantees i ts h igh s tability.