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Characterization Of A High Performance Duplex Stainless Steel For

Orthopedic Applications

Conference Paper · December 1990

DOI: 10.1109/IEMBS.1990.692178 · Source: IEEE Xplore

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 CHARACTERIZATION OF A HIGH PERFORMANCE DUPLEX STAINLESS STEEL
FOR ORTHOPEDIC APPLICATIONS

A.CigadaI, F.Amici Jr.2, M.Cavallini3,G.De Santis4, A.M.Gatti5,

M.Giacomazzi6, G.Rondelli7, A.Roos8, B.Vicentini7, D.Zaffe9

IDipartimento Chimica Fisica Applicata, Politecnico di Milano (Italy)

21stituto Clinica Ortopedica e Traumatologica, Universita La Sapienza di Roma (Italy)
3Dipartimento Ingegneria Chimica, Materiali, Materie Prime e Metallurgia, Universita La Sapienza di Roma (Italy)
4Clinica Ortopedica, Universita di Modena (Italy)
5Laboratorio Biomateriali, Clinica Odontoiatrica, Universita di Modena (Italy)
6G.Cremascoli S.p.A., Milano (Italy)
71stituto Tecnologia Materiali del Consiglio Nazionale delle Ricerche, Milano (Italy)
%andvik Steel, Sandviken (Sweden)
9Istituto Anatomia Umana, Universita di Modena (Italy)

ABSTRACT orthopedic devices, like Harrington rods for the treatment of

In the paper are illustrated the results of an extensive
investigation performed by a research working group constituted
by nine laboratories, with the target to study a material
alternative to the traditional ASTM FI 38 austenitic stainless
steel. In particular a 25Cr-7Ni-4Mo-0.28N austeno-ferritic
duplex stainless steel, with high molybdenum and nitrogen
contents, was developed. All the in vitro, in vivo on animals,
and clinical results obtained till now have shown that the
proposed steel can be suggested as a convenient substitute for
the ASTM F138 steel because it is not susceptible to crevice
corrosion in the human body and has better mechanical
properties (in particular better fatigue resistance) than the
traditional one.
INTRODUCTION
Austenitic stainless steels, according to the ASTM F138
Specification or AISI 316L type, are usually utilized for the
manufacture of osteosynthesis devices and other orthopedic
components characterized by the following properties:
- temporary implantation;
- necessity of a low cost of the material;
- suitable hot and cold deformation properties and
machinability.
However these materials do not achieve completely
satisfactory results for some clinical applications, [I ,211 due
to the following reasons:
- They are susceptible to localized crevice corrosion,
particularly under the heads of the screws fixing the
osteosynthesis plates to the bone and in the contact zones
between two or more endomedullary nails in the osteosynthesis
of lateral fractures of the proximal femur neck. In these
cases the localized corrosion attacks are facilitated by the
presence of fretting corrosion in the dynamic contact zones
among the different nails, and can cause a release of
metallic ions to the surrounding biological tissues; the
diffusion of the ions, in particular nickel ions, can lead to
local irritations and systemic effects. Some authors assert
that this phenomenon plays an important role in clinical
unsuccesses in this area.
They have insufficient mechanical properties and particularly
insufficient fatigue resistance for some very highly stressed
the scoliosis and sliding-compression plate-screw systems.
Mechanical failures of these components have been reported.
A coordinated research working group was constituted by
nine university, government and industry laboratories with the
target to set up an alternative solution to the use of the
traditional austenitic stainless steels, maintaining the
advantages of these steels, but overcoming their application
limits.
RESULTS
The attention was paid to the duplex stainless steels,
which, owing to a suitable balance between chromium and nickel
have a two phases structure, formed by about 50% of ferrite and
50% of austenite. Some steels of this class were studied. It
was demonstrated that [3] to obtain properties suitable to the
applications, it was necessary to use a duplex stainless steel
with
- high molybdenum content (=4%) to have a better localized
corrosion resistance;
- high nitrogen content (=0.3%) to have a further increase of
the localized corrosion resistance, a significant increase of
the mechanical properties of the steel and to avoid elements
partitioning between the austenitic and the ferritic phases.
Consequently a 25Cr-7Ni-4Mo-0.28N duplex stainless
steel (SAF 25-07) was developed and industrially processed by
Sandvik Steel.
The in vitro performances of the steel are summarized in
Table I , compared with those of the other tested steels. The
tests have shown in particular that:
- In many tests the behavior of the austenitic stainless steel
according ASTM F138 Specification, with low inclusion
content, i s better than traditional AISI 316L steel, however
in crevice conditions their behaviors are similar, pointing
out risks of crevice corrosion in an environment similar to
that of the human body. This confirms the results of the
retrieval analysis.
- Also the behavior of the traditional 22Cr-5.5Ni-3Mo-0.16N
duplex stainless steel is not completely adequate.
- The high performance 25Cr-7Ni-4Mo-0.28N duplex stainless
steel shows a very good behavior in all the tests, better
than the high alloy 27Cr-31Ni-3.5Mo austenitic stainless
steel, and it can be considered not susceptible to crevice
corrosion in the human body.

2082 Annual International Conference of the IEEE Engineering in Medicine and Biology Society, Vol. 12, No. 5, 1990
CH2936-3/90/0000-20a2$01.00 0 1990 IEEE

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 Table 1. In vitro localized corrosion results

Austenitic stainless steels Duplex stainless steels

AISI 3 16L 27Cr-31Ni-3.5Mo 22Cr-5.5Ni-3Mo-0.15N
ASTM F138 23Cr-4Ni-0.15N 25Cr-7Ni-4Mo-0.28N
Critical potentials of
localized corrosion (mVvsSCE)
- ASTM F746 test1 +225 +300 >+SO0 +150 +400 >+SO0
- Scratch test2 +400 +550 >+SO0 +300 +650 >+SO0
- Potentiodynamic test2
breakdown +500 +600 >+SO0 +500 >+800 >+SO0
repassivation 0 +IO0 >+so0 +50 -150 >+SO0

Critical temperature of
localized corrosion oncet (°C)293
- Pitting at +200 mVvsSCE 60 >80 >IO0 50 >70 >IO0
- Pitting at +350 mVvsSCE 25 70 100 35 65 >I00
- Crevice at +200 mVvsSCE <25 25 >60 <25 45 >90
- Crevice at +350 mVvsSCE <25 <25 35 <25 35 90
.....................................................................................................
NaCl 0.9% - 37°C
NaCl 8.74 g/l, NaHC03 0.35 g/l, Na2HP04 0.06 g/l, NaH2P04 0.06 g/l - 40°C or increasing temperature
3 Corrosion potential in the human body: +200/+350 mVvsSCE according to Hoar and Mears
.....................................................................................................

An in vivo investigation on sheep and rabbits was Moreover the results of these latest tests confirm the
performed to check the biocompatibility of the material possibility that the in vivo crevice corrosion of the ASTM F138
following much as possible the ASTM F361 Standard Practice and steel can take place also independently of the existence of
to test the in vivo localized corrosion resistance utilizing a fretting corrosion, which can have an effect of stimulation of
special device on purpose set up [4]. the crevice corrosion.
From microradiographs and SEM observations of the An extensive characterization of the mechanical
rabbits and sheep femur sections, a certain bone growth close properties of the 25Cr-7Ni-4Mo-0.28N steel was also performed,
to the implants of 25Cr-7Ni-4Mo-0.28N duplex stainless steel, in comparison with ASTM F138 steel [5]; special attention was
without interposed connective tissue, was observed. The EDS paid to the fatigue resistance of the material. Some results
microanalyses of the bone near the implant did not show are summarized in Table 2.
diffusion of metallic ions. The phosphorus/calcium ratio in the
new bone at the interface was similar to that of the old bone.
.......................................................
As far as the tests on special localized corrosion Table 2. Mechanical properties and fatigue resistance (MPa)
devices are concerned, either after 26 weeks or after 52 weeks
implantation time, the tests showed (Figure I): ASTM FI 38 25Cr-7Ni-4Mo-0.28N
- pitting corrosion on the AISI 304L (without molybdenum) Cold working degree
austenitic stainless steel ; (reduction of area %) UTS TYS UTS TYS
- crevice corrosion on the ASTM F138 austentic stainless steel; 0 584 255 898 609
- no corrosion at all on the 25Cr-7Ni-4Mo-0.28N duplex 31 912 831 1268 1185
stainless steel. 50 1138 1036 1392 1369
63 1255 1169 1506 1454
70 1344 1204 - -
A B C 76 1421 1252 - -
UTS Production Fatigue limit Fatigue limit

1080 industrially processed - 440

1450 industrially processed - 700-775
1400 laboratory melted 565-600
>480 industrially processed 283
1240 industrially processed 475-520

Fatigue limit range depends on different testing procedures

As can be noted, with the 25Cr-7Ni-4Mo-0.28N steel it’s

~i~~~~ 1. A~~~~~ of the specimens of the localized corrosion
devices after 52 weeks of implantation in rabbits; A: AISI 304
steel; B ASTM F138 steel; C: 25Cr-7Ni-4Mo-0.28N steel.
possible to obtain fatigue limits remarkably higher than those
of the ASTM F138 steel; this makes to guess an in vivo behavior
of prosthetic components manufactured with the proposed steel
better than this obtained with the traditional one. Also the
fatigue resistance in presence of sharp notches confirms the
previously reported situation.

Annual International Conference of the IEEE Engineering in Medicine and Biology Society, Vol. 12. No. 5. 1990 2083

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 Some wear tests were also performed on some materials For this purpose, an experimental set of 4.5 mm diameter
with different cold working conditions. According to the test Ender nails was manufactured, with 25Cr-7Ni-4Mo-0.28N
method, the edge of a hardened 750 HV counter specimen plate duplex stainless steel cold worked up to 1109 MPa yield
was worn against the plane of the test specimen with an strength and 1370 MPa ultimate strength.
oscillatory movement without using lubricants. The wear of the The nails were implanted in some patients for a period
test specimens and the counter specimens were determined by of about 6 months, and, after the propitious healing of the
weighting them before the test and after two and five hours of fracture, have been extracted and subjected to macroscopic
abrasion; the results are summarized in Table 3. examination.
In the case of the above mentioned application, a long
part of implanted traditional Ender nails made of ASTM F138
steel shows extensive crevice corrosion phenomena, with origin
in the contact zone between the nails. On the contrary, when
the 25Cr-7Ni-4Mo-0.28N steel was used, they presented very
(HV5) Test material Counter material limited fretting and no crevice corrosion (Figure 2).
2h 5h 2h 5h
ASTM F138 CONCLUSIONS
cold worked 401-412 11.2 25.6 0.6 0.8
25Cr-7Ni-4Mo-0.28N The results obtained during the present study clearly
annealed 257-246 9.0 20.4 0.1 0.8 pointed out that the 25Cr-7Ni-4Mo-0.28N duplex stainless steel
cold worked 401-447 9.3 21.0 0.4 0.9 can be considered a suitable alternative to the ASTM F138
CO-Cr-Mo alloy austenitic stainless steel for the manufacture of
cast 306-321 4.0 7.0 0 0.8 osteosynthesis devices or ortopedic components.
pure Titanium The steel showed the following features:
annealed 119-123 14.4 31.1 1.3 2.1 - it has very high localized corrosion resistance and can be
considered not susceptible to crevice corrosion in the human
body;
On the basis of all the above mentioned in vitro and in - it has higher mechanical properties than those of the today
vivo on animals results, a preliminar clinical investigation used austenitic stainless steel; in particular very high
was consequently started up. fatigue resistance can be reached.
As typical application, the osteosynthesis of the The good behavior in vitro of the 25Cr-7Ni-4Mo-0.28N
lateral fracture of the femur neck was choosen. with the (SAF 25-07) duplex stainless steel has been confirmed both by
insertion of two or more endomedullary nails, Ender type [6]. in vivo investigation on animals, and by the clinical
experiences that have been performed.

REFERENCES
[ l ] J.T.Scales, B.M.Roantree, R.Perry, R.Eborall, "Ten years of
fixation of fracture", Eng. Medi., 2(3), 51-57 (1973).
[2] A.M.Weinstain et al., "Orthopedic implant retrieval
analysis study", in Corrosion and Degradation of Implant
Material, ASTM STP 684, B.C.Syrett and A.Acharya (eds.),
ASTM, Philadelphia, 212-228 (1979).
[3] A.Cigada, G.Rondelli, B.Vicentini, M.Giacomazzi, A.Roos,
"Duplex Stainless Steels f o r Osteoshyntheis devices",
J. Biom. Mat. Res., 23, 1087-1095 (1989).
[4] A.Cigada, G.Rondelli, B.Vicentini, M.Giacomazzi, A.Roos,
"High Performance Duplex Stainless Steel for Orthopedic
Applications: Mechanical and Corrosion Properties",
Transactions of 15th Annual Meeting Society f o r
Biomaterials, pp.153, Lake Buena Vista, April 28-May 2,
1989.
[ 5 ] A.Cigada, G.De Santis, A.M.Gatti, M.Giacomazzi, G.Ronde1-
li, A.Roos, B.Vicentini, D.Zaffe, "High Performance Duplex
Stainless Steel for Orthopedic Applications: in Vitro and
in Vivo Results", Transactions of 16th Annual Meeting
Society for Biomaterials, Charleston, May 20-23, 1990.
[6] F.Amici Jr., M.Cavallini, A.Cigada, "Aspetti biomeccanici e
sperimentali dei mezzi d i ost$osintesi", Atti del 74"
Congress0 della Societa Italiana d i Ortopedia e
Traumatologia, Roma, November 12-15, 1989.

Mailing address:
Prof. Alberto Cigada
Dipartimento di Chimica Fisica Applicata
Politecnico di Milano
Figure 2. Aspect of Ender nail after about 24 weeks of piazza Leonard0 da Vinci 32
implantation in the human body, A: ASTM F138 steel, B: 25Cr- 20133 MILAN0 (Italy)
7Ni-4Mo-0.28N steel. Phone (39)2-23993164 - Fax (39)2-23993180

2084 Annual International Conference of the IEEE Engineering in Medicine and Biology Society, Vol. 12, No. 5, 1990

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