Engineering Failure Analysis 9 (2002) 621–633

www.elsevier.com/locate/engfailanal

Failure analysis of surgical implants in Brazil

C.R.F. Azevedo*, E. Hippert Jr.
Laboratory for Failure Analysis, Instituto de Pesquisas Tecnológicas do Estado de São Paulo, PO Box 0141,
São Paulo ZIP 01064-970, Brazil

Received 27 May 2002; accepted 23 June 2002

Abstract
The present paper summarises cases of metallurgical failure analysis of two femoral compression plates and one
femoral nail-plate fabricated in stainless steel, one oral maxillo-facial plate for jaw reconstruction in commercially pure
titanium alloy, and several Nitinol wires. The experimental work consisted of visual inspection of the samples, mac-
roscopic and microscopic characterisation of the material, fractographic investigation of the fracture surface and
adjacent areas and chemical composition. The present investigation revealed that most of the implants investigated
were not in accordance with ISO standards and most of them presented evidence of corrosion assisted fracture. Addi-
tionally, some of the components revealed the presence of fabrication and/or processing defects, which contributed to
their premature failure. The implantation of materials that are not biocompatible may cause several types of adverse
effects in the human body and promote the premature failure of the implants, with immeasurable damages for the
patients and losses for the public investment. The local sanitary regulation agencies are strengthening the mechanisms
to avoid the commercialisation of surgical implants not in accordance with standards, including the adoption of
retrieval analysis of failed implants.
# 2002 Elsevier Science Ltd. All rights reserved.
Keywords: Retrieval analysis; Surgical implants; Fracture mechanisms; Corrosion; Prosthesis

1. Introduction

World-wide data reveals that approximately 100 million metallic surgical implants were installed in
human beings between 1940 and 1975 [1]. The most important markets for medical products are the United
States, with annual revenues at approximately US$62 billion, the European Union (EU) at US$40 billion
and Japan at US$20 billion [2]. In Brazil, the sector of medical products was responsible in year 2000 for
37,500 job positions, earning annual revenue of approximately US$3 billion (this corresponds to a rank of
seventh in the world) [3].
Surgical implants are usually submitted to aggressive working conditions in terms of corrosion, wear and
mechanical loading (static and dynamic) and the premature failure of metallic implants are influenced by

* Corresponding author. Tel.: +55-11-3767-4117; fax: +55-11-3767-4036.

E-mail address: crfaze@ipt.br (C.R.F. Azevedo).
URL: http://www.ipt.br

1350-6307/02/$ - see front matter # 2002 Elsevier Science Ltd. All rights reserved.
PII: S1350-6307(02)00026-2
622 C.R.F. Azevedo, E. Hippert Jr. / Engineering Failure Analysis 9 (2002) 621–633

several factors, which include: mechanical design; material selection; manufacturing practice; medical
installation procedure; postoperative complications; and patient’s misuse [4–7]. In the USA, a growing
number of legal actions have been established as a consequence of the failure of medical implants, which
was estimated to be lower than 1% in the 1970s. The present US legislation governing failure of medical
devices is rigorous with respect to manufacturers liability, the manufacturer being legally responsible for
their product’s performance [8–10].
In 1999, the Brazilian Government created the National Agency for Health Surveillance of Brazil
(ANVISA) to promote health safety of the population through the sanitary control of production and
trade of medical and odontological products and services, including medical devices [11]. Unlike similar
agencies found in the USA—The Food and Drugs Administration—and in the United Kingdom—The
Medical Devices Agency—the ANVISA has not established a general procedure to be adopted by health
professionals and manufacturers in cases of failure of surgical implants [11–13]. As these failures are not
reported to a regulatory agency, there is a lack of statistical data in Brazil concerning the failures of med-
ical devices in general (failure rate, main causes, conformity to standards, public expenditure with
reoperation, etc.).
The systematic investigation of retrieved surgical implants increases the knowledge regarding clinical
implant performance and interactions between implants and the body; and promotes the development of
biocompatible implant materials, encouraging design optimisation and medical device research [14–16].
The International Organization for Standardization (ISO) and the American Society for Testing and
Materials (ASTM) have developed standards, which cover the practices for analysis of retrieved medical
implants. In both, the general guidelines require that implants and related adjacent-tissue should be
removed very carefully to avoid damage, especially with respect to functional surfaces, such as the fracture
surface of broken implants and bearing surfaces of joint prostheses [17–21].
The present work investigates the failure of two femoral compression plates fabricated in stainless steel,
one femoral nail-plate in stainless steel, one oral maxillo-facial plate for jaw reconstruction in commercially
pure titanium, and several Nitinol (wrought nickel–titanium shape memory alloys) wires.

2. Experimental procedure

The experimental procedure consisted of visual inspection, macroscopic and microscopic characterisa-
tion using a Karl Zeiss Jena stereomicroscope and a Neophot microscope, fractographic investigation
using a JEOL 5200 electron scanning microscope equipped with energy dispersive spectrometer (EDS), and
chemical composition using a Shimadzu X-ray fluorescence spectrometer, a Thermo Jarrell Ash plasma
atomic emission spectrometer (ICP), a LECO direct combustion analyser, a Shimadzu flame atomic
absorption spectrophotometer (AAE) and a LECO inert gas fusion determinator. The results were com-
pared to the requirements of ISO standards.

3. Results and discussion

3.1. Femoral compression plates

Both femoral compression plates presented fracture along one of the screw-holes (see example in Fig. 1).
The fracture surfaces of both plates are composed of two distinct areas, being 90% of flat region (I) and
10% of fibrous region (II) (see respectively arrows A and B in Fig. 2(a). The detail of the flat regions
showed fatigue striations, of approximately 0.6 mm spacing, associated with the presence of secondary
cracking [see Fig. 2(b)–(c)]. Additionally, the plate hole countersink and the underside of the screw-head
 C.R.F. Azevedo, E. Hippert Jr. / Engineering Failure Analysis 9 (2002) 621–633 623

surfaces showed tangential marks of wear and corrosion [see Fig. 3(a)–(c)]. When two different members of
a component are in contact, small-amplitude oscillatory sliding displacements between the contacting sur-
faces may arise as a result of cyclic loading of one of the components, promoting the formation of oxide
debris, removing the protective oxide layer and creating surface irregularities. Additionally, the repassiva-
tion of the removed oxide layer will be inhibited in the presence of aggressive environments such as the
oxygen-depleted areas, which exist in the shielded areas on a metallic surface (beneath screw-heads holding
a plate, for instance) and intense local attack by corrosion-assisted mechanisms is further promoted [22,23].
In all prosthetic devices and particularly those having multicomponents, the regions of stress con-
centration often coincide with crevice areas where localised corrosion is more likely [24]. The presence of
surface irregularities increases locally the stress concentration and decreases dramatically the total fatigue-
life of the component [22] The results indicated that the failures of the femoral compression plates occurred
by a fretting-fatigue mechanism under the action of low nominal stresses (given by the high proportion of
flat region) andin unidirectional bending (see the topographic aspect of the fracture showing one origin of
the fracture). The chemical composition of both plates and the only screw available were not in accordance
with minimum requirements of ISO 5832-1, reducing the corrosion resistance of the material (see Table 1).
Finally, the presence of fretting corrosion in the femoral compression plates may suggest the loosening of
the plate-screws in the bone, although proper clinical investigation should be carried out to confirm the
hypothesis of bone resorption [4].

3.2. Femoral nail-plate

The fracture of the stainless-steel femoral nail-plate (non-cannulated type, presenting a 130
angle and T-
type cross-section) occurred in the region of the nail presenting severe reduction in thickness [see Fig. 4(a)],
which causes high stress concentration. There are many different types of nail cross-sectional geometries to
prevent the rotation of the implant after fixation, including 4-flange, U, V, I and H, each of them pre-
senting different resistance to bending and torque [25]. The present investigation has found no data
concerning T-type cross sections.

Fig. 1. Example of failure found in stainless steel femoral compression plates.

624 C.R.F. Azevedo, E. Hippert Jr. / Engineering Failure Analysis 9 (2002) 621–633

Fig. 2. (a) Fracture surface of the femoral compression plate showing flat and fibrous regions; (b) detail of the flat region showing
fatigue striations associated with secondary cracking.
 C.R.F. Azevedo, E. Hippert Jr. / Engineering Failure Analysis 9 (2002) 621–633 625

Table 1
Chemical analysis of the stainless steel implants

Implant %C %Mn %Si %Cr %Ni %S %P %Mo 3.3a%Mo+%Cr

Compression plate 1 0.010 1.69 0.37 16.8 12.7 0.003 0.020 2.5 25.1
Compression plate 2 0.010 1.9 0.56 17.8 13.9 0.004 0.020 2.1 24.7
Plate-screw 2 0.010 1.8 0.58 17.2 11.9 0.004 0.030 2.1 23.5
Femoral nail-plate 0.03 1.89 0.38 17.5 13.3 <0.002 0.02 2.1 24.5
ISO 5832–1/type D 0.03 max. 2.0 max. 1.0 max. 17.0–19.0 13.0–15.0 0.010 max. 0.025 max. 2.25–3.5 26.0 min.
ISO 5832–1/type E 0.03 max. 2.0 max. 1.0 max. 17.0–19.0 14.0–16.0 0.010 max. 0.025 max. 2.25–4.2 26.0 min.
a
n.d.=not determined.

The examination of the nail surfaces showed evidences of gross manufacturing defects, such as cutting
edges, crack (specially in the corners and along the bottom surface of the T cross-section) and machining
marks [see Fig. 4(b)]. The investigation of the fracture surfaces also revealed:

 the presence of two opposite flat areas [see regions C and D in Fig. 4(c)], featuring ledges [see arrows
in Fig. 4(c)], which indicate the existence of multiple fracture nucleation points, and fatigue stria-
tions [see Fig. 4(d)];
 the presence of a small central area [see region E in Fig. 4(c)], featuring ductile fracture [see presence
of dimples in Fig. 4(e)], typical of overload failure.

The present results indicated that the fracture of the femoral nail-plate was nucleated at several points of
high stress concentration (poor design associated with manufacturing defects), probably due to the pre-
sence of manufacturing defects in both surfaces of the device, associated with the poor design of the com-
ponent, which introduced points of high stress concentration. The fracture was propagated by a fatigue
mechanism, under the action of low nominal stresses (high proportion of flat areas) and reverse bending
(presence of two flat areas opposite each other and separated by a ductile fracture). Additionally, the lit-
erature [25] points out that the fatigue breakage of nail-plates and blade-plates is almost invariably
attributed to a technical error by the surgeon when he fails to achieve a mechanically stable reduction of
the fracture. Finally, the chemical composition of the material was not in accordance with the minimum
requirements of ISO 5832-1 (see Table 1).

3.3. Titanium oral maxillo-facial plate

The oral maxillo-facial plate for jaw reconstruction failed along one of the notch-like recesses [see
Fig. 5(a)]. Microstructural examination revealed the presence of intergranular precipitation of b phase [see
Fig. 5(d)]. The chemical composition and the a grain size were in accordance with the requirements of ISO
5832–2, grade I (commercially pure titanium) (see Table 2). The EDS microanalysis indicated that the
plate-screws were manufactured in Ti–6Al–4V alloys, with Al and V contents in accordance with the
requirements of ISO 5832–3 (see Table 2). Commercially pure titanium usually features a reduction of area
of approximately 55% during tensile testing, but gross plastic deformation was not observed near the
fracture surface, suggesting that the failure took place by the action of a brittle mechanism [see Fig. 5(b)].
Fractographic investigation revealed the presence of a variety of fractographic features such as fissure
striations, complex furrow structures and secondary intergranular cracking [see Fig. 5(c)–(d)]. These dif-
ferent features were previously associated with the occurrence of fatigue in a-titanium [26,27].
Investigation of the Ti plate surface also revealed the presence of intense localised attack, except in the
surface in contact with the bone. The plate surface near the fracture origin showed the additional presence
626 C.R.F. Azevedo, E. Hippert Jr. / Engineering Failure Analysis 9 (2002) 621–633

Fig. 3. (a) Presence of wear and corrosion marks on the surface of the femoral compression plate hole near the fracture surface; (b)
plate screw head showing wear and corrosion marks on the contacting surface; (c) detail of the corrosion and wear marks on the screw
head.
 C.R.F. Azevedo, E. Hippert Jr. / Engineering Failure Analysis 9 (2002) 621–633 627

of intergranular cracking [see Fig. 5(f)]. These results indicate that fracture of the CP Ti plate occurred by a
corrosion-fatigue mechanism, originated at a plate notch. The additional presence of intense localised
corrosion and cracking near the fracture origin promoted the premature fatigue failure of the plate. The
origin of the localised corrosion could not be established and further work will be carried out [28].

3.4. Nitinol wires

Wrought nickel–titanium (Nitinol) based products have been on the market since the late 19600 s due to
Nitinol’s thermal shape memory behaviour (for instance as heart valve sizer tools). Today the emphasis has

Fig. 4. (a) Failure of an stainless steel femoral nail-plate in the region of severe reduction in thickness; (b) presence of manufacturing
defects on the nail surface, such as cutting-edge and machining marks (see arrow C); (c) general view of the fracture surface showing
two flat regions (arrows C and D) and a central fibrous area (arrow E); (d) detail of the fatigue striations found in regions C and D; (e)
detail of the ductile fracture (dimples) in the region E.
628 C.R.F. Azevedo, E. Hippert Jr. / Engineering Failure Analysis 9 (2002) 621–633

Fig. 5. (a) Failure of an oral maxillo-facial plate for jaw reconstruction; (b) general view of the fracture surface showing radial marks
(arrow A) converging from the fracture origin (arrow B); (c) and (d) detail of the fracture surface revealing various fractographic
features such as secondary cracking, complex furrow marks and fissure striations; (e) intergranular precipitation of b-phase; (f) selec-
tive attack and intergranular cracking on the external surface of the plate near the fracture origin.
 C.R.F. Azevedo, E. Hippert Jr. / Engineering Failure Analysis 9 (2002) 621–633 629

Table 2
Chemical analysis of the titanium plate and plate-screws and Nitinol wires

Device %Al %V %O %N %C %H %Ni Ti

Ti plate – – 0.09 0.006 <0.1 0.003 – Balance

Ti plate screws (mean) 4.61.8 4.50.4 n.d.a n.d. n.d. n.d. n.d. Balance
Nitinol wire – – 0.04 – 0.05 – 55.4 Balance
ISO 5832–2 – – 0.45 max. 0.05 max. 0.1 max. 0.0125 max – Balance
C.P Ti grade 1
ISO 5832–3 5.5–6.75 3.5—4.5 0.2 max. 0.05 max. 0.08 max. 0.015 max – Balance
Ti-6Al-4V alloy
Nitinol – – 0.05 max. – 0.02 max. – 54.5–57.0 Balance
ASTM F2063–00
a
n.d.=not determined.

shifted to its superelastic properties and there are several applications in the medical device industries, for
instance as hip implants, bone spacers, bone staples, bone anchors, skull plates, vascular and non-vascular
stents, and medical guidewires [28–30]. Nitinol alloys contain approximately 50 at.% of nickel, a fact which
causes great concern due to nickel’s citotoxicity. Its microstructure, however, is formed by a intermetallic
compound (TiNi), which presents a strong bonding force between nickel and titanium atoms, resulting in a
corrosion resistant microstructure. Additionally, Nitinol forms a protective TiO2 layer after proper surface
treatment, which is responsible for its high biocompatibility. Polarisation testing in Hank’s solution has
repeatedly shown that Nitinol is chemically more stable and less corrosive than stainless steel, as long as
there is a thin and uniform protective layer of TiO2 film [28–30].
The present study investigated the failure of several Nitinol orthodontic wires during service [see
Fig. 6(a)]. The fracture surfaces of the Nitinol wires indicated a predominantly ductile fracture mode with
large proportions of corroded areas [see Fig. 6(b)–(d)]. The large pitting corrosion regions were associated
with superficial defects observed on the wires and acted as stress raisers, promoting the premature failure
of the wires by overload. EDS microanalysis on the region adjacent to the corrosion surface [see Fig. 6(e)]
showed a composition of approximately 80% Ti and 20% Ni. These results were compared to the alloy’s
bulk composition, revealing that the regions adjacent to the corrosion surface were depleted in nickel. This
observation indicates the action of a mechanism of selective corrosion of nickel. A similar mechanism was
proposed in previous research investigating the corrosion behaviour of orthodontic wires [31].
The selective attack occurred preferentially near the superficial defects, which were generated during the
manufacturing process (wire-drawing and wire-picking process). Previous work has shown that the pre-
sence of manufacturing defects decreases dramatically the corrosion resistance of Nitinol alloys as they
remove the protective TiO2 layer [32]. Additionally, Ni–Ti shape memory alloys present in the potentio-
static scratch tests a difficult and slow TiO2 repassivation process [33], exposing the base-metal to the
selective dissolution of nickel and promoting pitting and crevice corrosion [31–33]. Finally, the chemical
compositions of the Nitinol wires (see Table 2) were not in accordance with the requirements of the ASTM
standard specification for wrought nickel–titanium shape memory alloys for medical devices and surgical
implants [34].

4. Final remarks

The present investigation revealed that most devices were not in accordance with the requirements of
ISO standards and most of them presented corrosion-assisted fracture mechanisms. The implantation of
materials that are not biocompatible may cause several types of adverse effects in the human body (from
630 C.R.F. Azevedo, E. Hippert Jr. / Engineering Failure Analysis 9 (2002) 621–633

allergic reactions to neurological disorders, metabolic bone diseases and even neoplasia) [35–37] and pro-
mote the premature failure of the implants, with immeasurable damages for the patients and losses for the
public investment [38,39]. Additionally, some of the devices (such as the Nitinol wires, the stainless steel
nail-plate and the Ti oral maxillo-facial plate) revealed the presence of fabrication or assembly defects,
which also contributed to their premature failure.

Fig. 6. (a) Nitinol wires; (b) general view of the fracture surface showing surface defects and massive corrosion; (c) detail of the
fracture surface showing ductile fracture; (d) acicular microstructure and the progression of lateral cracking; (e) detail of the lateral
cracking.
 C.R.F. Azevedo, E. Hippert Jr. / Engineering Failure Analysis 9 (2002) 621–633 631

The National Agency for Health Surveillance of Brazil (ANVISA) and the Brazilian National Health
Service (SUS), responsible for the consumption of more than US$40 million in implants [40], are currently
creating tough mechanisms to avoid the commercialisation of surgical implants that are not in accordance
with Brazilian (standards) ABNT. Additionally, ANVISA will adopt the practice of retrieval analysis of
failed implants, requesting that failures in medical devices should be meticulously investigated and repor-
ted to the local regulation agencies. The practice of implant retrieval protects the public health by identi-
fying and preventing the main causes of failure in surgical implants, and providing subsidies to the solution
of litigation cases.
The technical and economical statistical data which is generated by these analyses may identify and solve
the problems of the orthopaedic sector in Brazil, guiding manufacturers, traders, doctors and users of
metallic implants about the importance of the quality of the surgical implants. In this sense, the globali-
zation of standards has become an increasingly important issue in developing countries that are establish-
ing their own medical equipment industries and regulatory control [41]. The Brazilian market should,
therefore, optimise its quality system and begin to pay close attention to the export opportunities in the
emerging markets, which are estimated at US$15.6 billion.

5. Conclusions

1. The present investigation revealed that the stainless steel femoral compression plates and, femoral
nail-plate, titanium oral maxillo-facial plate and Nitinol wires were not in accordance with the
requirements of ISO standards;
2. The failures of the stainless steel femoral compression plates occurred by a fretting-fatigue
mechanism under the action of low nominal stresses and unidirectional bending;
3. The fracture of the femoral nail-plate occurred by a fatigue mechanism, under the action of low
nominal stresses and reverse bending. The fracture was nucleated in several points, probably due to
the presence of manufacturing defects in both surfaces of the device, associated with the poor design
of the component, which introduced points of high stress concentration;
4. The failure of the oral maxillo-facial titanium plate occurred by corrosion-fatigue promoted by the
presence of intense localised corrosion and intergranular cracking;
5. The failure of the Nitinol wires occurred by overload caused by the intense formation of pitting
corrosion during service. The pitting was associated with the presence of superficial manufacturing
defects.

Acknowledgements

The authors wish to thank Dr. E. Albertin and Dr. T. Cescon, for institutional support and helpful
comments; the technicians Mr. G. Spera and Mr. A. P. da Silva, for the experimental work; Mr. T. Puga
Leivas (Instituto de Ortopedia e Traumatologia do Hospital das Clı́nicas) and Dr. R. Curtis (Guy’s and St
Thomas’s Medical and Dental School), for helpful assistance. Some of the facilities used during the
experimental work were obtained through the project for ‘‘Modernização dos Recursos de Capacitação
Micrestrutural do LMAF-IPT (99/10231-0)’’, sponsored by the Fundação de Amparo à Pesquisa do Estado
de São Paulo—FAPESP. This work was partially sponsored by the Secretaria da Ciência, Tecnologia e
Desenvolvimento Econômico do Estado de São Paulo.
632 C.R.F. Azevedo, E. Hippert Jr. / Engineering Failure Analysis 9 (2002) 621–633

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