The Journal of Bone & Joint Surgery

The Journal of Bone & Joint Surgery, Volume 83, Issue 4

Articles | April 01, 2001

Dislodgment of Polyethylene Liners in First and Second-Generation Harris-Galante Acetabular Components : A Report of Eighteen Cases

Alejandro González DellaValle, MD; Patricio Salonia Ruzo, MD; Stephen Li, PhD; Paul Pellicci, MD; Thomas P. Sculco, MD; Eduardo A. Salvati, MD

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Investigation performed at The Hospital for Special Surgery, New York City
Alejandro González Della Valle, MD Department of Orthopedics, Hospital Italiano de Buenos Aires, Potosí 4215, Buenos Aires C1199ACK, Argentina. E-mail address: agdv@bigfoot.com
Patricio Salonia Ruzo, MD Department of Orthsopedics, Hospital Militar Central de Buenos Aires, 11 de Septiembre 1301, Buenos Aires 1426, Argentina. E-mail address: patricio@bigfoot.com
Stephen Li, PhD Paul Pellicci, MD Thomas P. Sculco, MD Eduardo A. Salvati, MD Departments of Biomechanics (S.L.) and Orthopedic Surgery (P.P., T.P.S., and E.A.S.), The Hospital for Special Surgery, 535 East 70th Street, New York, NY 10021. E-mail address for S. Li: lis@hss.edu. E-mail address for P. Pellicci: pelliccip@hss.edu. E-mail address for T.P. Sculco: sculcot@hss.edu. E-mail address for E.A. Salvati: salvatie@hss.edu
One or more of the authors has received or will receive benefits for personal or professional use from a commercial party related directly or indirectly to the subject of this article. In addition, benefits have been or will be directed to a research fund, foundation, educational institution, or other nonprofit organization with which one or more of the authors is associated. Funds were received in total or partial support of the research or clinical study presented in this article. The funding sources were the Mr. Lawrence M. Gelb Foundation and The Fanwood Foundation.

J Bone Joint Surg Am, 2001 Apr 01;83(4):553-553

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Abstract

Background:

Dislodgment of the polyethylene liner is an increasingly common complication following total hip arthroplasty. The purposes of this study are to present the results in a series of patients with this complication and to analyze the mode of failure.

Methods:

Between November 1995 and January 2001, eighteen patients who had had a total hip arthroplasty presented with dislodgment of the polyethylene liner from a Harris-Galante metal acetabular shell. The medical records, radiographs, operative notes, and retrieved components were reviewed. In addition, scanning electron microscopy was used to study the fractured surfaces in a shell that had four broken tines.

Results:

The components had been in situ for an average of seven years (range, three to eleven years). Seventeen components were second generation, and one was first generation. Symptoms developed spontaneously in sixteen patients, during sexual intercourse in one, and following a fall on the hip in one. Radiographs showed eccentric positioning of the head in all of the hips and broken tines in six. All of the shells were well fixed. Treatment consisted of revision of the shell in four patients, exchange of the liner in four, cementation of a new liner into the shell in seven, and cementation of an all-polyethylene cup in three. The liners had severe damage of the rim. Scanning-electron microscopy of the fractured surfaces of four tines revealed a fatigue pattern.

Conclusions:

We believe that, as the liner wears and becomes loose because of an inadequate locking mechanism, progressive micromotion occurs and the load increases on the polyethylene rim until it deforms and/or fractures. Subsequently, nothing prevents the liner from rotating out of the shell. As this mechanism of failure appears to include fatigue failure of the locking tines and wear of the liner, this complication is likely to increase as the components age in situ.

Figures in this Article

Introduction

Introduction | Materials and Methods | Results | Discussion | References

Cementless modular hemispheric acetabular components provide excellent long-term fixation with bone ingrowth, especially if they are inserted with a press-fit technique^1-3. Modularity allows access to the inner surface of the shell for the placement of screws to enhance the initial fixation. When wear occurs, the bearing surface can be exchanged without disturbance of the bone-shell interface if the locking mechanism is intact.

However, the use of these implants has led to problems associated with modularity. These problems include backside wear (wear of the polyethylene liner against the inner surface of the metal shell)^4,5; increased wear of the bearing surface^6,7; metal debris generated by fretting between the shell and the screws; and failure of the locking mechanism, leading to dissociation of the liner from the metal shell^8-12.

Recently, Louwerse and Heyligers¹⁰ reviewed the literature and found that thirteen of twenty-six reported cases of liner dislodgment had occurred in association with a Harris-Galante cup (Zimmer, Warsaw, Indiana)¹³. Those authors analyzed dislodgment in eight components with different locking mechanisms, including seven modular components and one component that had been preassembled in the factory¹⁰.

The purposes of this study are to report eighteen new cases of liner dislodgment in first and second-generation Harris-Galante acetabular components and to analyze the mode of failure.

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Fig. 1:: Anteroposterior radiograph of the right hip, demonstrating eccentric positioning of the femoral head, a broken tine, and a curved radiolucent image of the dislodged liner (arrow).

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Fig. 2:: The typical dislodged polyethylene liner demonstrates a deformed, fractured, and everted rim (black arrows). The metal shell demonstrates broken and bent tines and abrasion of the superolateral inner surface (white arrow) produced by articulation with the cobalt-chromium head following dislodgment of the liner.

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Fig. 3:: Electron microscopy of the fractured surface of a broken tine revealed findings consistent with a fatigue fracture.

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TABLE I: Patient Data

Case	Gender, Age at Implantation (yr)	Time in Situ (yr)	Type of Op.	Generation of Implant	Associated Event	Treatment	Delay in Treatment (day)
?1	F, 42	?5	Primary	II	Spontaneous	Liner exchange	?7
?2	F, 79	?3	Primary	II	Spontaneous	Liner exchange	25
?3	M, 33	?8	Revision	II	Fall on hip	Liner exchange	?3
?4	F, 39	?9	Primary	II	Spontaneous	Cemented liner	30
?5	M, 33	?7	Primary	II	Spontaneous	Liner exchange	?4
?6	F, 48	?5	Primary	II	Sexual intercourse	Shell revised	?4
?7	M, 44	?6	Primary	II	Spontaneous	Shell revised	10
?8	M, 65	11	Primary	I	Spontaneous	Cemented liner	15
?9	F, 31	?7	Primary	II	Spontaneous	Cemented liner	15
10	F, 54	?7	Primary	II	Spontaneous	Cemented liner	?5
11	M, 53	?7	Primary	II	Spontaneous	Shell revised	?7
12	F, 69	?8	Primary	II	Spontaneous	Cemented liner	?8
13	F, 65	?7	Primary	II	Spontaneous	Cemented liner	?7
14	F, 56	?8	Revision	II	Spontaneous	Cemented liner	?8
15	M, 51	?7	Primary	II	Spontaneous	Shell revised	13
16	M, 43	11	Primary	II	Spontaneous	Cemeted all-polyethylene cup	?3
17	F, 65	?8	Primary	II	Spontaneous	Cemeted all-polyethylene cup	11
18	F, 77	?7	Primary	II	Spontaneous	Cemeted all-polyethylene cup	?7

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TABLE I: Patient Data

Case	Gender, Age at Implantation (yr)	Time in Situ (yr)	Type of Op.	Generation of Implant	Associated Event	Treatment	Delay in Treatment (day)
?1	F, 42	?5	Primary	II	Spontaneous	Liner exchange	?7
?2	F, 79	?3	Primary	II	Spontaneous	Liner exchange	25
?3	M, 33	?8	Revision	II	Fall on hip	Liner exchange	?3
?4	F, 39	?9	Primary	II	Spontaneous	Cemented liner	30
?5	M, 33	?7	Primary	II	Spontaneous	Liner exchange	?4
?6	F, 48	?5	Primary	II	Sexual intercourse	Shell revised	?4
?7	M, 44	?6	Primary	II	Spontaneous	Shell revised	10
?8	M, 65	11	Primary	I	Spontaneous	Cemented liner	15
?9	F, 31	?7	Primary	II	Spontaneous	Cemented liner	15
10	F, 54	?7	Primary	II	Spontaneous	Cemented liner	?5
11	M, 53	?7	Primary	II	Spontaneous	Shell revised	?7
12	F, 69	?8	Primary	II	Spontaneous	Cemented liner	?8
13	F, 65	?7	Primary	II	Spontaneous	Cemented liner	?7
14	F, 56	?8	Revision	II	Spontaneous	Cemented liner	?8
15	M, 51	?7	Primary	II	Spontaneous	Shell revised	13
16	M, 43	11	Primary	II	Spontaneous	Cemeted all-polyethylene cup	?3
17	F, 65	?8	Primary	II	Spontaneous	Cemeted all-polyethylene cup	11
18	F, 77	?7	Primary	II	Spontaneous	Cemeted all-polyethylene cup	?7

Materials and Methods

Introduction | Materials and Methods | Results | Discussion | References

There were eleven women and seven men, with an average age of sixty years (range, thirty-eight to eighty-four years). The average age of the patients at the time of the arthroplasty was fifty-three years (range, thirty-one to seventy-nine years) (Table I). The average height of the patients was 168 cm (range, 150 to 197 cm), and the average weight was 80 kg (range, 58 to 115 kg). The average time from implantation until the onset of symptoms was seven years (range, three to eleven years). The right side was affected in eleven patients and the left side, in seven.

Radiographs that were made at the time of admission were compared with earlier ones to determine the position of the dislodged liner, the presence of broken tines from the locking mechanism, and the orientation and fixation of the metal shell.

Sixteen patients had had a primary arthroplasty, one had had reimplantation following deep infection (Case 3), and one (Case 14) had had revision following recurrent dislocations. The preoperative diagnosis was osteoarthritis in twelve patients, avascular necrosis in four, Marfan syndrome in one, and congenital hip dislocation in one.

Seventeen patients had a second-generation Harris-Galante cup, and one (Case 8) had a first-generation cup. The external diameter of the metal cup averaged 54 mm (range, 50 to 62 mm). Screws were used in eight hips (average, 2.5 screws; range, two, three, or four screws). Sixteen patients had a cemented femoral component; of these, fifteen had an Omnifit component (Osteonics, Allendale, New Jersey) and one had a Charnley component (DePuy, Warsaw, Indiana). The remaining two patients (Cases 4 and 9) had an Omnifit microtextured component (Osteonics) that had been inserted without cement. Two patients (Cases 4 and 14) had a 22-mm femoral head, one (Case 10) had a 26-mm head, and the remaining fifteen had a 28-mm head.

Seventeen of the polyethylene liners and all four revised metal shells were available for analysis. The linear wear of the retrieved liners was determined by measuring the difference in polyethylene thickness between the superior and inferior margins with a digital caliper (Micrometer Digimatic; Mituyo, Tokyo, Japan) according to the method proposed by Li et al.¹⁴.

Scanning electron microscopy (1000A; AMRay, Bedford, Massachusetts) was used to examine the fractured surfaces of four broken tines from the shell retrieved from one of the patients (Case 6).

Results

Introduction | Materials and Methods | Results | Discussion | References

None of the patients had clinical evidence of mechanical failure before the onset of symptoms. The symptoms started acutely in most of the patients and included hip pain, clicking and instability, limb-shortening, and a coxalgic gait. The onset of symptoms was spontaneous in sixteen patients. In one patient symptoms followed a fall on the hip, and in another female patient the symptoms began during sexual intercourse when both legs were held in abduction and external rotation. In two of these patients, the dislodgment was misdiagnosed as a dislocation and an attempted closed reduction at another hospital failed; radiographs made at the time of admission to our hospital revealed that the hip was initially displaced because of dislodgment of the liner.

Radiographic evaluation at the time of the onset of symptoms revealed eccentric positioning of the head within the cup in all of the hips. A radiolucent image produced by the inferior displacement of the liner between the inferior part of the neck of the femoral prosthesis and the inferior rim of the shell was seen on the radiographs of fourteen hips. Radiographs demonstrated one to four broken metal tines (average, two broken tines) in six cups (Fig. 1). In one patient (Case 7), an active fifty-year-old man who presented with dislodgment six years after bilateral total hip replacement, an asymptomatic broken tine was first seen on a routine radiograph that had been made one year before the dislodgment.

All of the acetabular components were found to be radiographically well fixed according to the criteria of Gruen et al.¹⁵ and DeLee and Charnley¹⁶. The average inclination of the acetabular component as measured on anteroposterior radiographs was 43 (range, 40 to 50), and the average anteversion was 18 (range, 10 to 30) according to the method of Ackland et al.¹⁷.

The average delay from the onset of symptoms to the revision was ten days (range, three to thirty days). During revision surgery, blackening of the periprosthetic tissues with metal debris was detected in seventeen patients. The dissociated liner was displaced inferiorly and posteriorly in seventeen patients. In the remaining patient, the liner was in place but was grossly loose; the superolateral rim of the liner was severely damaged and deformed, allowing the liner to easily rotate in and out of the shell.

On the acetabular side, treatment consisted of revision of the well-fixed shell in four patients, exchange of the polyethylene liner in four, cementation of a new liner into the shell with the technique of LaPorte et al.¹⁸ in seven, and cementation of an all-polyethylene cup in three. On the femoral side, three patients (including the one with a Charnley stem) had revision of the stem with the cement-within-cement technique¹⁹ after macromotion was detected between the stem and the cement mantle. The remaining fifteen patients had an exchange of the modular head. Mild corrosion of the Morse taper was observed in four patients. All patients had an uneventful recovery.

The average annual linear wear of the polyethylene liner was 0.17 mm (range, 0.01 to 0.39 mm). Backside wear, indicated by the absence of machine lines and by severe scratching, was observed on all seventeen liners that were available for analysis. Numerous deep linear scratches on the equatorial backside of the liners had occurred as a result of fretting against the inferior rim of the metal shell following dislodgment. All of the liners had damage to the superolateral rim (Fig. 2), and one liner had a fracture extending from the polar region to the superior rim.

All four retrieved metal shells had broken and bent tines (Fig. 2). In one patient, four of the eight tines had broken off the shell (Case 6). Scanning electron microscopic examination of the fractured surfaces of these four tines revealed findings consistent with fatigue fracture (Fig. 3). Additionally, the inner surface of the metal shells demonstrated blackening and scratching resulting from the articulation of the cobalt-chromium head against the titanium-alloy shell, following dislodgment of the liner.

Discussion

Introduction | Materials and Methods | Results | Discussion | References

Liner dislodgment has been described in association with numerous modular and nonmodular acetabular components, including the PCA preassembled cup (Porous-Coated Anatomic; Howmedica, Rutherford, New Jersey)⁹, the PCA modular cup (Howmedica)^10,11,20, the JMP cup and the Anderson screw cup (Joint Medical Products, Stamford, Connecticut)¹⁰, the APR cup (Anatomic Porous Replacement; Intermedics, Austin, Texas), the Schütt and Grundei cup (Lübeck, Germany)¹⁰, the ACS cup (Acetabular Cup System; Depuy, Warsaw, Indiana)¹⁰, and the Harris-Galante cup (Zimmer)^{1-3,8,10,12,21-30}.

The Harris-Galante component was introduced in 1984. The hemispheric metal shell is made of titanium alloy, with a layer of titanium fiber mesh for bone ingrowth. The locking mechanism consists of four pairs of titanium tines in the rim that lock into a circumferential slot in the liner. The second-generation component was released in 1988 with several modifications, including an increased number of tines, arranged in a different configuration, in the larger models. The thickness of the shell also increased, from 3.7 to 5.6 mm in the small models and from 4.7 to 5.6 mm in the larger models. Additionally, the diameter of the cancellous bone screws increased from 5.1 to 6.5 mm^31-34.

The manufacturer’s records indicate that 165,000 Harris-Galante-II cups were implanted in the United States between 1988 (the year the device was released ) and 1998. The original Harris-Galante model has not been discontinued, and an additional 46,000 Harris-Galante-I components were implanted from 1988 to 1998. Despite the modifications in the locking mechanism, we are aware of three reports of dissociation of the liner from a Harris-Galante-II cup^12,21,22.

Castro et al. reviewed 1033 Food and Drug Administration Medical Device Reports of failed hip-replacement implants³⁵. Failure of modular acetabular components was reported twice as frequently as failure of femoral components; the most frequent modes of failure were fracture (254 [38%] of 666 reports) and dislodgment (228 [34%] of 666 reports) of the polyethylene liner³⁵. Most of these reports were submitted after 1990, suggesting an increasing incidence of liner dislodgment in the last decade. Castro et al. believed that, despite the efforts of the Food and Drug Administration to achieve higher rates of compliance, the rate of reporting of these cases is low and results in underestimation of the prevalence of this complication³⁵.

The prevalence of liner dislodgment associated with each type of Harris-Galante component is difficult to calculate because the type of Harris-Galante cup implanted is not always described^{2,6,8,23,24,27,28,36,37} and, as both models have been available since 1988, the date of surgery is not helpful in determining which model was implanted.

Incavo et al. did not mention liner dislodgment in a report on the early results of sixty-six Harris-Galante cups that had been followed for an average of 36.8 months²³. However, one dislodgment was reported three years later, in an updated follow-up³⁸. Although the number of Harris-Galante cups implanted at our hospital decreased from 781 in 1991 to zero in 1999, we observed five dislodgments between December 1995 and February 1998 and thirteen in the last two years, with the last four occurring within two months (between November 2000 and January 2001). We believe that this complication is time-related and that it most likely will continue to increase. Three important contributors to dislodgment are all time-dependent: (1) the fatigue-associated deformation or breakage of the titanium-alloy tines; (2) the increased micromotion in the shell-liner interface due to polyethylene degradation, deformation, and wear (both of the articulating surface and of the backside); and (3) impingement of the neck and the liner rim, which increases as the wear progresses.

Tradonsky et al. examined the in vitro push-out and lever-out strength necessary to dissociate the liner from the metal shell in eight unused modular acetabular components with five different locking mechanisms³⁹. The push-out and lever-out forces required to dissociate Harris-Galante-II components were less than those required to dissociate other cups, suggesting that the original locking mechanism may be deficient. Additionally, in order to test the locking mechanism after dissociation, the polyethylene liners were reseated. The torques required for liner separation were consistently lower than the torques measured in the initial tests. Three Harris-Galante-II cups so tested had an average reduction of 25% of the initial strength. Macroscopic examination demonstrated bending of the tines and damage to the liner. When the lever-out strength was tested with new liners, similar results were observed³⁹. Weakness of the liner restraints could be expected despite the apparent integrity of the tines. This scenario can occur either when new liners are seated following a dislodgment or during elective liner exchange. In the present study, the locking mechanism appeared to be intact when examined macroscopically after eleven of the eighteen dislodgments. Cameron et al. reported dissociation of a liner four months after an elective liner exchange²¹.

Numerous factors could potentially combine with a weak locking mechanism to produce a dislodgment: trauma, dislocation, component malalignment, impingement, torque, and plastic wear of the articular surface or of the backside^10,39,40.

The tolerance range within which the metal shell and the liner are manufactured could potentially explain an increase in early micromotion if a liner manufactured with the minimum tolerance is seated in a shell built with the maximum inner-diameter tolerance. Similarly, a human error causing mismatch (the implantation of a liner that is smaller than the metallic shell) or incomplete seating of the liner could explain early dislodgment (that occurring less than six months postoperatively).

We believe that, as the liner loosens because of wear and a weak locking mechanism, load is applied to the rim until the polyethylene deforms and/or fractures. Once the polyethylene rim deforms and/or fractures, nothing prevents the liner from rotating out of the metal shell.

Radiographic evidence of a broken tine should raise concern about the potential risk of dislodgment, and the patient should be informed accordingly. We observed such progression in a patient (Case 7) who presented with a dislodgment six years after implantation and one year after a broken tine was detected on routine follow-up radiographs. Additionally, broken tines can be sources of third-body wear if they are trapped in the joint space⁴¹.

Patients with Harris-Galante cups should be monitored for radiographic evidence of failure of the locking mechanism. Younger and more active patients may be more prone to this complication. The average age of our eighteen patients at the time of implantation was fifty-three years, as opposed to sixty-five years for the patients managed with primary total hip arthroplasty in the overall experience of the three senior authors (P.P., T.P.S., and E.A.S.). Paradoxically, it is for these young patients that the use of uncemented modular acetabular components has been advocated⁴². A review of a large database of 1021 primary total hip replacements that were performed in 989 patients by the three senior authors between 1994 and 1999 revealed that the eighteen patients with dislodgment had the same average height (168 cm) and weight (80 kg). Osteoarthritis was a less frequent diagnosis among the patients with dislodgment (66% [twelve of eighteen] compared with 88% [872 of 989])⁴³.

When a dislodgment is diagnosed, revision should be carried out urgently to minimize metal wear. We observed blackening of the soft tissues in seventeen patients, including both patients who underwent revision surgery only a few days after the onset of symptoms. Delay in the revision may lead to severe damage to the metal shell and progressive bone loss^10,21,27. The degree of metallosis was proportional to the time between the onset of symptoms and revision surgery. Four of our first five patients were treated with liner exchange, with an uneventful course at an average duration of follow-up of one and one-half years. However, we are concerned about the potential risk of another dislodgment when a new liner is seated despite an apparently intact locking mechanism. At the time of surgery, we prefer revision of the metal shell, particularly if it has no holes, or cementation of a new all-polyethylene cup if the metal shell has holes. We recommend revising the shell when there is good acetabular bone stock, when the cup is laterally positioned or is malaligned, or when cementing an all-polyethylene cup in a very small shell could compromise the cement mantle or polyethylene thickness. In the latter instance, if the well-fixed stem is modular, downsizing to a 22-mm head will provide a thicker polyethylene. As the use of cemented all-polyethylene cups is sparse, attention should be paid to the date of sterilization, as polyethylene degrades with age. The cemented all-polyethylene cup may increase leg length by a few millimeters, necessitating a shorter prosthetic neck. Conversely, in older, low-demand patients, we recommend cementing a new all-polyethylene cup if the shell has multiple holes or if there is poor acetabular bone stock.

To our knowledge, this is the largest series of dislodgments with this cup design from a single institution. The manufacturer of Harris-Galante cups has abandoned this locking mechanism in favor of new modular cups. However, these components are still commercially available and this problem will continue to be encountered.

References

Introduction | Materials and Methods | Results | Discussion | References

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Topics

fracture ; metals ; polyethylene ; hip joint prosthesis, acetabular component ; liner dislodgement

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Alejandro González DellaValle, Patricio Salonia Ruzo, Stephen Li, Paul Pellicci, Thomas P. Sculco, Eduardo A. Salvati; Dislodgment of Polyethylene Liners in First and Second-Generation Harris-Galante Acetabular Components A Report of Eighteen Cases. The Journal of Bone & Joint Surgery. 2001 Apr;83(4):553-553.

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