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Preliminary Study on the Biocompatibility of Stainless Steel 316L and

UHMWPE Material

Article  in  Advanced Materials Research · August 2015

DOI: 10.4028/www.scientific.net/AMR.1123.160

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Advanced Materials Research Submitted: 2014-08-23
ISSN: 1662-8985, Vol. 1123, pp 160-163 Revised: 2015-02-06
doi:10.4028/www.scientific.net/AMR.1123.160 Accepted: 2015-03-31
© 2015 Trans Tech Publications, Switzerland Online: 2015-08-26

Preliminary Study on the Biocompatibility of Stainless Steel 316L and

UHMWPE Material

I.B. Anwar1,2,a , E. Saputra2,3, J. Jamari3 and E. Van der Heide2,4

1
Orthopaedic and Traumatology Department, Prof. Dr. R. Soeharso Orthopaedic Hospital Jl. A.
Yani Pabelan, Surakarta 57162, Indonesia
2
Laboratory for Surface Technology and Tribology, Faculty of Engineering Technology, University
of Twente Drienerloolaan 5, Postbox 217, 7500 AE, Enschede, The Netherlands
3
Laboratory for Engineering Design and Tribology, Department of Mechanical Engineering,
University of Diponegoro, Jl. Prof. Soedharto, Tembalang, Semarang 59275, Indonesia
4
TNO, Postbox 6235, 5600 HE Eindhoven, The Netherlands
a
iwanbudiwan@yahoo.com

Keywords: biocompatibility, stainless steel 316L, UHMWPE, implant.

Abstract. Stainless steel AISI 316L (SS316L) and ultra-high molecular weight polyethylene
(UHMWPE) are widely used materials for artificial hip joint components. The SS316L material is
typically used for the acetabular cup, femoral head and the stem, while the UHMWPE material is
used for the acetabular liner in an artificial hip joint. The aim of this work is to study the
biocompatibility of SS316L and UHMWPE materials by implanting and installing these materials in
the tissues of rabbits. The tissues around the implants were examined after eight weeks of the
installment. Results showed that the reaction of the rabbit tissues around the implants was positive.
It was concluded that the SS316L and the UHMWPE materials are biocompatible and the
applications of these materials for implants seems conceivable.

Introduction
Generally, the presence of implant in a human body may cause certain reactions in muscle tissue
and bone. The biomaterial that is implanted into the body must meet the function of the body system
without causing adverse reactions to one another, i.e. must be biocompatible [1,2]. Furthermore, the
implant material must have stable physical and mechanical properties, and the implant should be
relatively easy to fabricate, reproduce, and meet the technical and biological requirements [3]. Most
of the orthopedic implants are used in the skeletal system, e.g. as an artificial hip joint or as an
artificial knee joint.
Implants and prostheses from SS316L and UHMWPE materials for domestic orthopedic
purposes in Indonesia are developed and manufactured by several companies. However, the
biocompatibility analysis of these materials, available in the domestic market of Indonesia, is not
reported yet. Therefore, a biocompatibility study of these SS316L and UHMWPE materials is
necessary and performed in this work by analyzing the muscle and the bone tissue reactions in a
rabbit model.

Materials and Experimental Procedures

The implants used in this study are the SS316L and the UHMWPE materials, while the object of
the study is a local rabbit (Lepus sp). The materials of SS316L and UHMWPE are obtained from the
domestic market in Indonesia. The materials properties are given in Tables 1, 2 and 3. These
properties were obtained from material testing in our laboratory. In this study is not focus in the
composition of these materials but only focus in the biocompatibility of these materials. Therefore,
the detail information of these materials in this paper is not presented.

All rights reserved. No part of contents of this paper may be reproduced or transmitted in any form or by any means without the written permission of Trans
Tech Publications, www.ttp.net. (ID: 182.255.0.4-18/02/16,03:28:10)
 Advanced Materials Research Vol. 1123 161

The geometry of the SS316L implants was calculated by using the ratio of the length of the 8-
hole broad plate implant with a length typically for the femur of Indonesian people [4]. The length
of the 8-hole broad plate implant and the average of Indonesian femur are 134 mm and 447 mm,
respectively, so a ratio of 30% is found. Therefore, the SS316L implant that was used for the
experiment was made at the same 30% ratio of the size of the rabbit femur. A similar approach was
applied to the UHMWPE sample. The dimension of the UHMWPE implant was determined by the
ratio of the acetabular liner outer diameter of an artificial hip joint (AHJ) and the femoral head outer
diameter, typically used for Indonesian people.

Table 1. Composition of the SS316L material.

Element (wt. %) Element (wt. %)
Fe 65.2 Mo 1.01
C 0.0136 Ni 14.7
Si 0.421 Al 0.0383
Mn 1.90 Co 0.420
P <0.0050 Cu 0.645
S 0.0210 Nb 0.312
Cr 14.5 Ti 0.0775

Table 2. The mechanical properties of the SS316L material.

Yield stress Macro hardness Micro hardness
(MPa) (HRA) (VHN)
356.14 MPa 64.5 197 VHN

Table 3. The mechanical properties of the UHMWPE material.

Yield stress Macro hardness Flexural Strength Flexural Modulus
(MPa) (VHN) (MPa) (GPa)
25.25 8.8 18.71 ± 0.63 0.67 ± 0.05

Eleven rabbits (Lepus sp) with an average weight of 1 kg were employed for the experiment. The
SS316L samples were implanted in the right femur of the rabbit, one implant sample per rabbit. The
same holds for the UHMWPE samples. After the end of the test period of eight weeks, the rabbits
were euthanized with a lethal dose of ketamine IM injection of 200 mg/kg [5]. The implant
extraction was performed after the no sign of life was confirmed. This action was performed using
sepsis antisepsis technique. After that, muscle and the bone tissue of the rabbit was cut into samples
for further macroscopic and microscopic histological analyzes. The samples were stored in a Bouin
liquid before the histological analyzes.

Results and Discussion

SS 316L. Figure 1 shows the macroscopic results of the SS316L implant sample. It can be seen
from the macroscopic appearance that there is no difference between the muscle and the bone
tissues adhered to the implant sample compared to the reference tissues. The macro anatomical
change was not observed. The yellow arrow is the comparative samples of the muscle tissue and the
green arrow is the comparative samples of the bone tissue.
The microscopic histological analyzes were performed by an optical microscope. Most of the
samples observed revealed no significant reaction between the sample and the muscle tissue and
between the sample the bone tissue. Only minor fibrosis and bone regulars were observed for two
samples. There was no metal debris found in all the samples. Fibrosis tissue development is one of
the main responses of the body when there is an implant present. The fibrosis layer may consist of
inflammatory cells and a necrotic area [6]. The minor fibrosis tissues may be caused by an
162 Advanced Materials Science and Technology II

inflammation due to the integration process (not encapsulated). Figure 2.(a) shows the example of
the minor fibrosis for the muscle tissue and Fig. 2.(b) shows an illustrative example of the minor
irregularity of the bone tissue. The results of the present study confirm well the results of Erdman, et
al. [7]. Erdman et al. compared the muscle tissue reaction of the SS316L implant and the
biodegradable (MgCa0.8) implant. It was found that both implants are accepted well by the body.
Inflammation is observed after the removal process of the implant, but it disappears after six weeks
indicating that the inflammation is may be caused by the surgery process. There are no tissue-
cavities found in [7], although tissue cavities are commonly observed for the biodegradable
implants. Huehnerschulte, et al. [8] show that the tissue cavities could cause the periosteal new bone
formation.

SS316L sample

Fig. 1. Macroscopic appearance of the muscle and the bone in the area where the SS316L sample
is implanted.

Fig. 2. Histological analyses (Hematoxicilin & Eosin colouring, magnification 40X) after
implantation of the SS316L for (a) the minor fibrosis at the surface of the muscle and (b) the surface
of the irregular bone.

UHMWPE. Similar results were also found for the UHMWPE implant samples. Almost all the
samples show no significant reaction between the UHMWPE implant with the bone and the muscle
tissues. All the UHMWPE implant were prominently visible in the joint of the rabbit without
inflammation or dehiscence. No UHMWPE debris was found in all the samples.
Figure 3.(a) shows an illustrative example where there was no inflammation or dehiscence in the
area near the adhered implant. From the histological analyses it was also concluded that there is
almost no fibrosis or bone irregularity. Figure 3.(b) shows an example of the histological result of
the bone tissue. No evidence for bone irregularity was found.
 Advanced Materials Research Vol. 1123 163

Fig. 3. (a) Condition of the area near to the UHMWPE implant. (b) Histological analyses picture
of the bone tissue after the removal of the UHMWPE implant.

Conclusion
A preliminary study on the biocompatibility between the SS316L material and the UHMWPE
material and the mammalian body (rabbit) tissues was performed. The materials were implanted
into the body tissues and after eight weeks the tissues around the implant were analyzed. Analyzes
were conducted macroscopically and microscopically. Results show that the SS316L material and
the UHMWPE material, available at the Indonesian domestic market, did not significantly trigger
the reactions of the muscle tissue and the bone tissues. It was concluded that the SS316L and the
UHMWPE materials are biocompatible and the applications of these materials for implants seems
conceivable.

References
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[2] G. Voggenreiter, S. Leiting, H. Brauer, P. Leiting, P. Majetschak, M. Bardenheuer, U.
Obertacke, Immuno-inflammatory tissue reaction to stainless-steel and titanium plates used for
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 Advanced Materials Science and Technology II
10.4028/www.scientific.net/AMR.1123

Preliminary Study on the Biocompatibility of Stainless Steel 316L and UHMWPE Material
10.4028/www.scientific.net/AMR.1123.160

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