Engineering Failure Analysis 25 (2012) 261270

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Engineering Failure Analysis

journal homepage: www.elsevier.com/locate/engfailanal

Cause of an implant fracture: Material- or fabrication failure?

R. Wallstabe , C. Klinger
BAM Federal Institute for Materials Research and Testing, Division 9.1 Service Loading Fatigue and Structural Integrity, Unter den Eichen 87, D-12205
Berlin, Germany

a r t i c l e i n f o a b s t r a c t

Article history: Intramedullary hip screws (IMHSs) are implanted for the xture of pertrochanteric femoral
Received 2 February 2012 fractures (thigh bone). The present work investigates the failure of an IMHS implant after
Received in revised form 9 May 2012 the rehabilitation period which required a revision surgery where the upper femur had to
Accepted 14 May 2012
be replaced by a hip endoprosthesis. Due to litigation the corresponding failure analysis
Available online 5 June 2012
was conducted at BAM Federal Institute for Materials Research and Testing and is the sub-
ject of this article. By order of the customer failure causes due to material and fabrication
Keywords:
failures should be particularly investigated. Therefore, thorough fractographic, chemical as
Implant fracture
Intramedullary hip screw (IMHS)
well as metallographic investigations were carried out. In order to assess possible fabrica-
Austenitic steel tion failures selected dimensions of the components were compared with the technical
Laser-marking drawings and the surface topography was analysed.
Implant placement The investigation revealed several causes for the fracture of the lag screw which is the
implant component intended to x the position of the femoral head. These are in descend-
ing order of relevance: (1) the screw was placed incorrectly and therefore had a smaller
bending stiffness, (2) the femoral fracture zone was not stable, i.e., the lag screw moved
out of its proper position and (3) the laser marking on the lag screw was relatively large
and led to a metallurgical notch at the now, because of the above mentioned points,
severely stressed region. A material- or fabrication failure was not the root cause for the
fracture of the lag screw. It was mainly due to its incorrect placement during surgery
and the instability of the bone fracture. Furthermore, the implant geometry with 130
was not well-suited for the patients anatomy. A 135-IMHS might have been biomechan-
ically preferable. Based on the determined failure causes and inuences a relative lifetime
estimation led to about 10% of the lifetime of a correctly placed 135-IMHS assuming a suf-
ciently stable bone fracture zone.
2012 Elsevier Ltd. All rights reserved.

1. Introduction and disease chronology

Fractures of the femoral head (pertrochanteric femoral fractures) are treated as far as possible by applying minimal inva-
sive surgery using implants to stabilize the fracture. There are several implant systems available by different manufacturers
that apply the lag screw-nail-principle such as gamma-nail, classic-nail (IMHS), proximal femural nail (PFN) or dynamic
hip screw (DHS) [1,2]. All of them possess specic advantages but also disadvantages [15]. The major advantage for most
of these implants is that the treatment of old patients (in average over 80 years) of pertrochanteric femoral fractures allows
nearly full weight bearing immediately after surgery and only few complications in most cases [1,2,6]. Thus, patients can be
mobilised in an early stage after surgery.

Corresponding author. Tel.: +49 (0)30 8104 3142; fax: +49 (0)30 8104 1537.
E-mail address: Ronald.Wallstabe@bam.de (R. Wallstabe).

1350-6307/$ - see front matter 2012 Elsevier Ltd. All rights reserved.
http://dx.doi.org/10.1016/j.engfailanal.2012.05.010
262 R. Wallstabe, C. Klinger / Engineering Failure Analysis 25 (2012) 261270

An intramedullary hip screw (IMHS) of the type classic nail was used in the present case to x a pertrochantric femoral
fracture. The components of a classic nail IMHS comprise a nail, a lag screw, a keyed centering sleeve, a compression screw,
a set screw and at least one cortical bone screw (Fig. 1a). Applying this kind of system the fracture zone of the femoral head
can be set under compression. The possible sliding of the lag screw inside the key centering sleeve is intentional. The afore-
mentioned issues allow a higher compression of the fractured femoral head which is supposed to have biomechanical advan-
tages and to be benicial to the healing process [7].
In the present case the fall of a patient aged about 80 years led to a pertrochanteric femoral fracture (Fig. 1b). The fracture
was treated by an osteosynthesis, i.e., by implanting an IMHS (Fig. 2a). Afterwards the patient was mobilised by physiother-
apeutic exercices during stationary rehabilitation for 3 weeks. Radiography revealed that the fracture was not consolidated
completely (Fig. 2bd). About 3 months after surgery the patient was admitted to hospital because of severe pain in the thigh
region. The radiographs showed a fractured lag screw (Fig. 2e). Please note that this radiograph was taken only couple of
days after Fig. 2d. During revision surgery the fractured IMHS was removed to allow tment of a hip endoprothesis, this
meant signicant bone-loss. The patient had to stay in hospital for another 2 weeks.

Fig. 1. (a) Components of an IMHS implant (manufacturer markings on nail and lag screw are camouaged) and (b) radiograph of the patients initial
fracture. The femoral head is fractured.

Fig. 2. Radiographic chronology: (a) at surgery (image converter), (b) 1 week after surgery, (c) 2.5 months after surgery, (d) ca. 3 months after surgery and
(e) before revision surgery only a couple of days after the preceding radiograph. The moving-out of the lag screw is visible starting from (b).
 R. Wallstabe, C. Klinger / Engineering Failure Analysis 25 (2012) 261270 263

2. Failure investigations

2.1. Visual inspection

With the exception of the lag screw all explanted components of the IMHS were still intact in the sense of not functionally
failed. The lag screw was fractured into two pieces (Fig. 2e). The femoral side with bone thread was named LS-1 and the other
piece with compression screw was named LS-2. Indications for corrosive attack were not found.
The centering sleeve showed a noticable depression resulting from the mounted set screw. The depression is located 23
relative to the vertical symmetrical plane which is parallel to the guiding planes of the sleeve. There were also some mark-
ings at the ends of the inner side that were possibly caused by the fractured parts of the lag screw.
The nail had noticable plastic deformation at the slotted hole for the cortical bone screw that indicates a rotation of the
nail in its vertical axis.
For the IMHS used for comparison there was a rotational looseness of about 10 between the lag screw and the centering
sleeve with mounted set screw. For the failed IMHS using fractured part LS-2 of the lag screw and the centering sleeve the
same rotational looseness of about 10 was found.

2.2. Fractography

The fractured lag screw parts LS-1 and LS-2 showed different features. The fractured surface of LS-1 was partly severely
mechanically damaged while the one of LS-2 remained in good condition. Thus LS-2 was selected for further investigations.
The fracture surface was cleaned in ultrasonic bath. LS-2 was examined using an Olympus SZX12 stereomicroscope and a
CamScan 2 Scanning Electron Microscope. Features of fatigue fracture were observed macroscopically. The fracture initiation
site was part of the M-shaped laser marking, which can be clearly seen for LS-2 (Fig. 3b).
SEM investigations revealed a fatigue fracture in different magnications (Fig. 4). Nearly the whole surface showed fati-
gue features, e.g., striations and beachmarks. The relatively small nal fracture showed exclusively shear dimples and was of
triangular shape with an angle of about 23 (Fig. 5a).

2.3. Materials investigations

Chemical analysis was performed on specimen LS-2-2 by Spark Emission Spectrometry (SES) using a device type Spectro-
lab, Spectro Analytical Instruments GmbH & Co. KG. Reported values are the average of six single measurements and have a
standard deviation of 10%. The results are presented in Table 1. The chemical composition is in accordance with the speci-
cation of the commercial material BioDur 316LS Stainless. The specied steel is a remelted (ESR-electroslag remelted or
VAR-vacuum arc remelted) quality of Type 316 Stainless resulting in improved cleanliness [8]. Due to its low carbon, higher
nickel and higher molybdenum content than Type 316 Stainless the microstructure is free of ferrite and it exhibits a higher
corrosion resistance [8]. The mechanical properties are after [8] in cold worked condition (35%) a 0.2% Yield strength of ap-
prox. 800 MPa, an ultimate tensile strength of approx. 850 MPa and a hardness of 26 HRC. For the annealed condition the
0.2% Yield strength is approx. 248 MPa, the ultimate tensile strength is approx. 586 MPa and the hardness is 88 HRB.
According to the material standard DIN ISO 5832-1:2008 [9], a purity determination according to ISO 4967:1998 (Method
A, Table 2) [10] as well as a grain size determination (assessment according to ISO 643 [11]) should be carried out for the lag
screw material. The microstructure must not contain any v- or r-phase. Microsections of specimen LS-2 (cf. Fig. 2) perpen-
dicular (LS-2-1-1) and longitudinal (LS-2-1-2) to the lag screw axis were prepared. The longitudinal microsection was pre-
pared through the laser-marking (cf. Fig. 3) in order to see possible changes in microstructure (Fig. 6a).

Fig. 3. Fracture surface of LS-2. Fatigue features, i.e., beachmarks, are visible. The crack initiation site is indicated by black arrows in (a) and (b). It partly
coincides with one of the horizontal lines of the laser-marking M, indicated by grey arrow in (b). Stereomicroscope, layer composite image.
264 R. Wallstabe, C. Klinger / Engineering Failure Analysis 25 (2012) 261270

Fig. 4. Fracture surface of LS-2. Initiation at lower edge of lag screw, indicated by arrow in (a). Fatigue features, i.e., beachmarks in (a) and (b) as well as
striations (c) and (d), are annotated exemplarily. SEM images.

Fig. 5. Fracture surface of LS-2. Final rupture area which is located under an angle of ca. 23 in (a). Higher magnication of (a) in (b). Shear dimples are
visible in (c) and (d), exemplary annotations. SEM images.
 R. Wallstabe, C. Klinger / Engineering Failure Analysis 25 (2012) 261270 265

Table 1
Results of chemical analysis by SES and comparison with specied values in [8]. All reported values are in wt.%.

C Si Mn P S Cr Mo Ni Cu N
Failed lag screw 0.03 0.46 2.00 0.016 0.004 17.64 2.72 14.85 0.07 n.a.
Specs BioDur 60.03 60.75 62.00 60.025 60.010 17.00 2.25 13.00 60.50 60.10
316LS stainless [8] 19.00 3.00 15.00

n.a. Due to the sample size this value could not be determined because a small aperture had to be used which led to a not detectable signal for nitrogen.

Table 2
Results of purity analysis according to ISO 4967:1998 [10] and comparison with values specied in DIN ISO 5832-1:2008 [9].

Inclusion type A (sulphides) B (aluminates) C (silicates) D (oxides, globular)

thin thick thin thick thin thick thin thick
Microsection lag screw 0.5
DIN ISO 5832-1 [9]
Specied max. values 1.5 1.0 1.5 1.0 1.5 1.0 1.5 1.0

Fig. 6. (a) Longitudinal microsection (LS-2-1-2) of LS-2 through laser-marking positions in etched condition. Microstructural changes and a crack are
visible. (b) Surface topography of LS-2 in the area of laser-marking.

The results of the purity class determination are shown in Table 2. The investigated area of the unetched longitudinal
microsection was 70 mm2, in contrast to the standard 200 mm2. This was due to geometric limitations of the component.
Inadmissable inclusions were not found. The grain size could only be determined approximately because of the present an-
nealed microstructure. The examined specimen showed grain size classes between 5 and 7 after DIN ISO 5832 [9] which cor-
responds to average grain sizes from 62.5 lm to 31.2 lm. The grain size meets the given specications. Carbides and d-ferrite
were not found in the areas without laser-marking. In the examined microsections v- and r-phase were also not found.
At the position of the laser-markings microstructural changes were found, i.e., a metallurgical notch (Fig. 6a). These areas
showed an altered microstructure with coarser grain size and small amounts of d-ferrite. Moreover, in the unetched condi-
tion layers, which appear grey in light microscopy, were found on the surface. These are most likely oxide layers that were
formed during the laser-marking process. Six cracks perpendicular to the specimens surface, which initiated at the different
laser-marking positions at the surface, were found in the longitudinal microsection. Crack length varies between approx.
40 lm and approx. 8 lm and decreases with increasing distance from the fracture surface, i.e., greatest crack length is in
direct vicinity to the fracture surface.
Vickers Hardness measurements HV 0.01 were performed using the semi-automatic Struers Duramin 10. The base mate-
rial showed no variation in hardness from the middle with 246 5 HV0.01 to the area about 100 lm below the surface with
246 8 HV0.01. For the two presented values 10 single position were measured and averaged. By comparison of the hardness
values to the specications [8] it can be derived that the base material was in cold worked condition of about 35% (approx.
270 HV).
The hardness indents for one exemplary laser-marking position are shown in Fig. 7a. The values range from 135 HV0.01
(pos. 1) to 173 HV0.01 (pos. 4) near the surface which corresponds roughly to the annealed condition (approx. 185 HV).
Hardness increases further to 201 HV0.01 (pos. 5) until it reaches the values of the base material of 251 HV0.01 (pos. 6)
and 251 HV0.01 (pos. 7) as well. The observed asymmetric indents (pos. 15) could arise either from a hardness gradient,
i.e. slight hardness increase in the near-surface region, or at least to some extent from the preparation, i.e. microsection
266 R. Wallstabe, C. Klinger / Engineering Failure Analysis 25 (2012) 261270

Fig. 7. Hardness indents at one exemplary laser-marking position in longitudinal microsection (LS-2-1-2) in differential interference contrast (a). Hardness
values are as follows: 135 HV0.01 (pos. 1), 153 HV0.01 (pos. 2), 173 HV0.01 (pos. 3), 137 HV0.01 (pos. 4), 201 HV0.01 (pos. 5), 251 HV0.01 (pos. 6) as well as
251 HV0.01 (pos. 7). Photomontage of hardness indents and micrograph showing the microstructure (b). Light microscope.

is crowned due to the polishing process. However, hardness is basically lower in the region affected by the laser-marking
than in the base material (Fig. 7b).

2.4. Manufacturing

Selected dimensions of lag screw and keyed centering sleeve were inspected. All dimensions were within the tolerances
specied in the technical drawings. In order to detect possible surface aws, e.g., sharp notches, the surface topography was
analysed by using a whitelight prolometer (FRT Microprof with CWL-sensor). The laser-marking depth was not evenly dis-
tributed and ca. 3 lm in maximum (Fig. 6b). Consequently, the inuence of geometric notches can be neglected in this case.
The laser-marking, although part of the manufacturing process, cannot be considered as a manufacturing failure, since it was
carried out appropriately. In summary, manufacturing failures that could be responsible for the fracture of the lag screw
were not found.

2.5. Implant placement and load analysis

Implant orientation and the orientation of the hip force resulting from bodyweight as well as the location of the Varus-
angle is depicted schematically in Fig. 8.
Due to markings on the keyed centering sleeve originating from the set screw the original placement in surgery could be
concluded. The lag screw was rotated by an angle u of 52 compared to the placement requested and documented in the

Fig. 8. Schematic view of human hip with femur: (a) front-view and (b) side-view. The direction of the hip force resulting from bodyweight is depicted in
(a) exemplarily for the left side. The so called Varus-angle of the femur is shown on the left side as well. In (a) on the right side the implant orientation is
shown schematically.
 R. Wallstabe, C. Klinger / Engineering Failure Analysis 25 (2012) 261270 267

Fig. 9. Correct placement of lag screw as documented in surgery manual (a) and actual (incorrect) placement of lag screw in surgery (b). The bending
loading resulting from hip force is around the y- or y-axis respectively. The hip force is shown on (a and b). The determined angles on (b) are as follows: lag
screw rotation in surgery 52, angle for hip force 15, possible rotation due to tolerances 10 (cf. Section 2.1) and the angle for the nal fracture area 23.
Please note that hip force and baseline for nal fracture area are perpendicular, as one would expect.

operation manual [12]. The rotation and its angle is supported by the fractographic ndings, i.e., angle of the nal fracture
area (Fig. 5).
Due to the erroneous placement of the lag screw its section modulus decreases and the maximum stress in the outmost
area increases under bending loading (around y-axis) resulting from the patient hip force. In order to assess the inuence of
wrong placement on the failure the main areal moments of inertia of the cross-section were determined by using standard
Computer Aided Design Software [13]. For bending around the y-axis an areal moment of inertia Iyy of 297 mm4 and for
bending around the z-axis Izz of 240 mm4 was determined (Fig. 9). By using the known main areal moments of inertia it
is possible to calculate the areal moment of inertia for a given rotation angle u by using Eq. (1). Since the prole is double
symmetric the last term containing Iyz equals zero.
The section modulus of the prole Wy or W y for the rotated prole respectively is given by Eq. (2). The maximum bending
stress rb;y ;max at the surface with outer bre distance a can be calculated by Eq. (3).

1 1
Iyy Iyy Izz Iyy  Izz  cos2u  Iyz sin2u 1
2 2

I yy
W y 2
a
M 
rb;y ;max b;y 3
Wy

Fig. 10 depicts the inuence of the rotation u on the loading conditions. The maximum bending stress is reached for a
rotation of u = 60. The rotation of the lag screw resulted in an increase of 16% for the maximum bending stress in compar-
ison to its correct placement (u = 0).
Although bending moments become slightly smaller due to the moving-out of the lag screw (cf. Fig. 2bd) the metallur-
gical notch effect of the laser-marking several cracks were found in these regions (Fig. 6) leads to critical loading condi-
tions, since the marking with its locally reduced fatigue strength is now located in a highly stressed area (Fig. 9b).

3. Failure causes and relative lifetime estimation

Several causes could be identied for the failure of this implant (Table 3). If one of the relevant causes had been missing,
the fracture of the lag screw would possibly not have taken place.
Firstly, the lag screw was not placed correctly during surgery. It was rotated ca. 52 leading to a stress rise of about 16%
(Fig. 10). Secondly, the laser-marking introduced a near-surface metallurgical notch in the lag screw. Due to the wrong place-
ment of the lag screw (rotation) the marking was in the highly loaded area (cf. Fig. 9b). Thirdly, the implant became biome-
chanically instable leading to a moving-out of the lag screw. For some patients with an IMHS-implant excessive sliding of the
lag screw and the collapse of instable fractures have been observed [14]. The movement of the lag screw could be possibly
related to the phenomenon termed cut-out or (reversed) z-effect in the medical literature [6,4,15,16] that seem to be the
268 R. Wallstabe, C. Klinger / Engineering Failure Analysis 25 (2012) 261270

Fig. 10. Areal moment of inertia Iyy , maximum stress increase Si, section modulus of the prole Wy and outer bre distance a plotted against rotation angle
u. Si is based on stress for correct placement (u = 0) with 100%.

Table 3
Relative inuence factors on loading, loadability and lifetime of lag screw. The factors are explained in Section 3. Abbreviation FC represents failure cause.
Values in brackets are spreading width of input values or results.

Inuence factors or their combination Loading-factor Loadability-factor Lifetime-factor

Ff Lf LTf
FC1 Lag screw rotation of 52 in surgery 1.15 1.0 0.40
(1.151.16)
FC2 Moving-out of lag screw 0.93 1.0 1.70
(1.000.83) (1.003.00)
FC3 Metallurgical notch effect due to laser-marking 1.00 0.9 0.50
FC4 Implant angle 130 instead of 135 1.16 1.0 0.35
Actual Combination of FC1 & FC2 & FC3 & FC4 1.24 0.9 0.10
Situation (1.331.11) (0.060.23)

two major complications for these implant types. Instability of the fracture could possibly affect the implant failure rate [17].
The laser-marking (metallurgical notch) was due to the moving-out of the lag screw in the position of even higher loading
since it was near the end of the keyed centering sleeve. Fig. 11 shows the reconstructed placement of the lag screw in the
IMHS prior to nal fracture.
Thus, mainly two major failure causes could be identied: (FC1) wrong placement of the lag screw during surgery
(Fig. 11), i.e., rotation of 52, and (FC2) not performing an indicated revision surgery after the biomechanical instability could
be derived from the radiographs, i.e., moving-out of the lag screw (Fig. 2). An additional cause was the metallurgical notch
(Fig. 6) due to the laser-marking (FC3). However, in case of correct placement and without the moving-out of the lag screw
the marking would have been near the neutral axis in a region with low loading. Furthermore, the used variant of the IMHS
with 130 was not the best available choice an also available IMHS with 135 would have been better for the actual patient
anatomy (FC4), i.e., biomechanically preferable due to a better t of implant and patient anatomy (Fig. 8). Thus, the 130-
IMHS had to bear an increased loading compared to the 135-IMHS.
Based on the investigated failure causes a relative lifetime estimation was carried out using a simplied S/N-curve for
austenitic steel with an exponent k = 7 [18]. The lifetime for a comparable 135-IMHS implant is used as base value. The re-
sults are shown in Table 3. Taking into account all inuences the lifetime of the investigated lag screw was reduced by a
factor of about 0.10, i.e., the 130-IMHS implant (rotated position) reaches only about 10% of the correctly placed 135-IMHS
implant.
 R. Wallstabe, C. Klinger / Engineering Failure Analysis 25 (2012) 261270 269

Fig. 11. Placement of IMHS implant components prior to fracture (manufacturer markings on nail and lag screw are alienated). Fracture position and
placement/movement deviations to the surgery manual are indicated by arrows.

4. Recommendations and preventive actions

Recommendations and possible actions to prevent possible future failures of this or similar implants can be summarised
as follows:

 Redesign regarding the possibility of erroneous implant placement by the application of the Poka Yoke Principle [19],
i.e., correct mounting/placement is ensured by means of unique geometrical t for the different component interfaces.
 Use of smaller laser-markings preferably at a different position, e.g., at the end faces of the lag screw.
 Critical observation of fracture zones and implants that seem to be biomechanically unstable and immediate revision sur-
gery if indicated.
 Choice of tting or suitable implant variants (Varus-angle) for individual patient anatomy by surgeon.

Please note that the apparent metallurgical notch effect by laser-marking as the root cause for the lag-screw-fracture
could only be falsied because of further extensive assessment of radiographs, disease chronology, surgery manual, and bio-
mechanical expertise. The present work serves as another example showing that one must carry out a thorough investigation
in the failure analysis of medical implants.

Acknowledgements

The authors would like to thank Ms. O. Paulinus and Mr. S. Bohraus for carrying out the metallographic as well as the
fractographic work. Furthermore, the fruitful discussions with colleagues of the Failure Analysis working group at BAM
are kindly acknowledged.

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