Orthopedics

Feature Article 

Recall of the ASR XL Head and Hip Resurfacing Systems

Werner Maurer-Ertl, MD; Joerg Friesenbichler, MD, PhD; Lukas A. Holzer, MD, PhD; Lukas Leitner, MD, PhD; Kathrin Ogris, MD; Michael Maier; Andreas Leithner, MD

Abstract

At the beginning of the 21st century, use of large-diameter, metal-on-metal devices was a popular procedure for hip replacement in young and physically active patients; however, within a few years, the number of revisions increased, resulting in a worldwide recall for the articular surface replacement (ASR) system. Complication rates for the ASR devices implanted at the authors' department are reported, with revision rates of 32% and 30% in the ASR XL Head and ASR Resurfacing groups, respectively. Reasons for revision surgery were serum metal ion elevation, luxation or subluxation, aseptic loosening, soft tissue compromise (adverse reactions to metal debris [ARMD]), and infection. The calculated implant survival for the ASR XL Head system and the ASR Resurfacing device (DePuy Orthopaedics Inc, Warsaw, Indiana) in the current series was 79% and 90%, respectively, at 60 months. Symptomatic patients with metal-on-metal devices, with or without elevated metal ion concentrations, should undergo cross sectional imaging to exclude ARMD. In cases of increased metal ion concentrations, local pain, or ARMD, revision surgery has to be evaluated. In the future, closer monitoring of new implants is needed to prevent high failure rates, as seen with the ASR design. Furthermore, the withdrawal of the device highlights the importance of national implant registries. [Orthopedics. 2017; 40(2):e340–e347.]

Abstract

At the beginning of the 21st century, use of large-diameter, metal-on-metal devices was a popular procedure for hip replacement in young and physically active patients; however, within a few years, the number of revisions increased, resulting in a worldwide recall for the articular surface replacement (ASR) system. Complication rates for the ASR devices implanted at the authors' department are reported, with revision rates of 32% and 30% in the ASR XL Head and ASR Resurfacing groups, respectively. Reasons for revision surgery were serum metal ion elevation, luxation or subluxation, aseptic loosening, soft tissue compromise (adverse reactions to metal debris [ARMD]), and infection. The calculated implant survival for the ASR XL Head system and the ASR Resurfacing device (DePuy Orthopaedics Inc, Warsaw, Indiana) in the current series was 79% and 90%, respectively, at 60 months. Symptomatic patients with metal-on-metal devices, with or without elevated metal ion concentrations, should undergo cross sectional imaging to exclude ARMD. In cases of increased metal ion concentrations, local pain, or ARMD, revision surgery has to be evaluated. In the future, closer monitoring of new implants is needed to prevent high failure rates, as seen with the ASR design. Furthermore, the withdrawal of the device highlights the importance of national implant registries. [Orthopedics. 2017; 40(2):e340–e347.]

Metal-on-metal (MoM) hip resurfacing and total hip arthroplasty (THA) became a popular procedure for joint replacement due to propagated favorable wear patterns and high range of motion, especially in young and physically active patients with high demand on the performance of the implant.1–6 Several manufacturers introduced hip resurfacing systems and large-diameter hip arthroplasty devices with different spherical features and designs. Overall, more than 600,000 MoM THA procedures were performed in the United States between 2006 and 2012.6 Nevertheless, over time the number of revisions for failed hip arthroplasties using MoM articulation increased. Especially high rates were seen following hip resurfacing due to increased metal ion concentrations, although the long-term effects of systemic exposure still remain unclear.2,3,7–15

The ASR XL Head and Resurfacing system (DePuy Orthopaedics Inc, Warsaw, Indiana) was first introduced in the United States in 2003 and commercially launched worldwide in April 2004.1,4,16 Initially, the ASR monobloc acetabular component was part of the resurfacing system; subsequently, it was also approved for the ASR XL Head system, which represented a modern MoM device.2 Overall, more than 100,000 ASR devices have been implanted worldwide.4,17

Within 3 years after the introduction of the system, the US Food and Drug Administration received innumerable complaints from patients who received ASR hip prostheses (Resurfacing and THA).17

In March 2010, DePuy Orthopaedics Inc acknowledged that the ASR products had a higher failure rate than other MoM devices compared with other manufacturers. This has been shown in the annual reports of the Australian Joint Replacement Registry hosted by the Australian Orthopaedic Association (AOA), as well as the National Joint Registry for England and Wales.1,3,5,17–19 The data revealed that approximately 12% to 13% of patients who received an ASR device needed revision surgery due to several complications.1,2,4,5,15,19–22

Several studies identified reasons for the failure of the hip replacement system as component loosening, component malalignment, infection, periprosthetic fracture, dislocation, metal sensitivity, and pain. Further complications from MoM devices include increased metal ion levels, aseptic necrosis of bone, and local soft tissue reactions (adverse reaction to metal debris [ARMD]).1–7,15,16,20–30

In August 2010, DePuy Orthopaedics Inc issued a voluntary recall of both ASR devices. Furthermore, the company published guidelines for the implant recall, including suggestions for patient management.3,31

The aim of the current study was to report the complications, revision rates, and implant survival of the ASR devices from the authors' institution.

Materials and Methods

Sixty-four ASR devices were implanted in 56 patients (20 ASR Resurfacing and 44 ASR XL Head) between 2005 and 2008. Eight patients received a bilateral THA, in all cases an ASR XL Head. There were 26 female and 29 male patients, with a mean age at operation of 51 years (range, 29–68 years). The demographic data of the patients is shown in Table 1.


Patient Demographics, Failure Rates, Component Details, and Metal Ion Concentrations

Table 1:

Patient Demographics, Failure Rates, Component Details, and Metal Ion Concentrations

Until the recall in 2011, most of the patients with ASR implants were included in an ongoing prospective clinical study (postmarketing surveillance study) determining serum metal ion concentrations. Therefore, blood was taken routinely at intervals of 6 to 12 months depending on the serum concentrations. Details have been published previously.32

Due to the voluntary recall, patients treated with an ASR implant at the authors' department were contacted and asked to participate in an intensive screening program to identify possible implant-related complications.

The extraordinary follow-up included clinical examination, plain radiographs, and serum metal ion determination. Furthermore, patients were referred to cross-sectional imaging using a metal artefact reduction sequence (MARS) magnetic resonance imaging (MRI),33 especially those who complained about pain or who showed serum metal ion concentrations higher than 7 µg/L. This boundary value was suggested by the world's largest orthopedic societies, such as the American Academy of Orthopaedic Surgeons, European Federation of National Associations of Orthopaedics and Traumatology, and British Hip Society, to be the limit for indicating revision surgery or continuous follow-up. Some patients refused MRI because they had no complications. Data acquisition was performed by a board-certified orthopedic surgeon (W.M.E.) and experienced orthopedic residents (J.F., L.A.H.).

Statistical Analysis

Collected data were processed for statistical differences between the implant groups (ASR XL head versus ASR resurfacing). Furthermore, differences between the revision and the nonrevision groups were determined concerning serum metal ion concentrations. Due to the asymmetric distribution of all parameters, nonparametric tests (Kolmogorov-Smirnov test, Mann-Whitney U test) were used. Implant survival was calculated according to the Kaplan-Meier method. P<.05 was considered statistically significant. For statistical analysis, the PASW Statistics version 16.0 program (SPSS Inc, Chicago, Illinois) was used. This study was approved by the Ethics Committee (EK17-265 ex 05/06), and written informed consent was obtained from all patients.

Results

ASR XL Head

In the ASR XL head group, there were 36 patients with 44 hip replacements. Eight patients had a bilateral hip replacement. Demographics are shown in Table 1. Mean postoperative follow-up was 78 months (range, 20–98 months). Two patients died due to a hepatocellular carcinoma at 20 and 67 months following index operation. Hematoxylin and eosin– stained sections, as well as Berlin blue– stained sections, were negative for metallic deposits in the tumor cells. Therefore, it can be stated that the carcinomas might not be related to the ASR devices.

In this patient group, 24 patients underwent MARS MRI of the hip due to elevated serum metal ion concentrations or due to pain. In 7 (29%) patients, ARMD could be detected.

Three revisions were performed before the recall: 2 (5%) due to chronic periprosthetic join infection in 1 patient at 61 months following index surgery and 1 (2%) due to dislocation at 39 months following implantation after failed closed reduction in another patient.

Eight (18%) implant revisions were performed due to elevated serum metal ion concentrations at a mean follow-up of 56 months (range, 38–83 months), and 3 (7%) revisions had to be done due to aseptic loosening of the femoral stem at a mean follow-up of 41 months (range, 14–56 months). In all 3 cases of aseptic femoral loosening, the ASR XL Head device was combined with a hydroxyapatite-coated Corail stem (DePuy Orthopaedics Inc). That aseptic loosening was related to metal debris is not proven due to the fact that there was no extensive local metallosis at the time of revision. On the other hand, 2 of the patients had elevated cobalt (Co) and chromium (Cr) concentrations at the time of revision, which might indicate a causal link. The overall revision rate for any complication was 32% in this group.

ASR Resurfacing

In the ASR resurfacing group, there were 20 patients with unilateral hip arthroplasty. Demographic data are also shown in Table 1. Mean postoperative follow-up was 86 months (range, 68–109 months). In this group, 11 patients underwent MARS MRI due to elevated serum metal ion levels and/or due to pain and ARMD was detected in 5 (45%).

Three (15%) revisions were performed due to ARMD. One patient underwent 2 (10%) revisions due to pseudotumor formation before conversion of the tribological pairing at 12 and 13 months following index surgery. The second patient was revised due to ARMD and an impending femoral neck fracture at 69 months following implantation.

For 1 (5%) female patient, revision surgery was performed due to dislocation immediately after implantation of the resurfacing device. A second revision surgery, changing the tribological pairing due to massive metal ion elevation and ARMD detection (5%) in the MRI, was performed 74 months after index surgery in the same patient. A further revision was done for subluxation (5%) at 72 months following index surgery due to implant malposition. The overall revision rate for any complication was 30% in this group.

Revision Surgeries

All revisions were performed through an anterolateral approach, and all ASR components were removed. In patients with the ASR XL Head system, the femoral stems (Corail or Future, DePuy Orthopaedics Inc) could be left in situ because all were found to be well integrated. In all cases, the periarticular soft tissues showed a blackish-grey coloring as a sign for metallosis. Cystic formations (ARMD) were resected and sent for histopathologic analysis. Supra- and periacetabular osteolyses were refilled using allogeneic cancellous bone grafts.

All cups were revised to press-fit implants such as Pinnacle Sector or Pinnacle Gription (DePuy Orthopaedics Inc) combined with a conventional 36-mm ceramic-on-ceramic (CoC) bearing. In all patients with a previously implanted stem in situ, a titanium sleeve (BioBall; Merete, Berlin, Germany) was used for taper connection. In case of revision of resurfacing devices, a press-fit, hydroxyapatite-coated Corail stem was used for femoral replacement.

Postoperatively, patients started mobilization with partial weight bearing for 6 weeks; thereafter, weight bearing was increased depending on clinical and radiological findings.

Serum Metal Ion Determination

Mean serum metal ion concentrations for Co and Cr were 18.7 µg/L (range, 0–190.5 µg/L) and 12.9 µg/L (range, 0.3–125 µg/L) in all patients treated with an ASR device at the time of implant recall in 2011. In the ASR XL head group, the mean concentration for Co was significantly higher compared to the resurfacing group (P<.001) (Table 1). For Cr, an opposite effect could be observed within these implant groups (P=.006) (Table 1).

Mean prerevision Co and Cr concentrations were higher in the revision groups than in the nonrevised groups, although the differences in the resurfacing group were statistically not significant (Table 2).


Serum Metal Ion Concentrations in the ASR Patients at Prerevision Follow-up

Table 2:

Serum Metal Ion Concentrations in the ASR Patients at Prerevision Follow-up

Implant Survival

According to the Kaplan-Meier method, the calculated implant survival with revision as the end point was 83% at 60 months for all ASR implants, which decreased to a survival of 73% at 96 months (Figure 1).


The Kaplan-Meier cumulative probability of implant survival of the articular surface replacement devices.

Figure 1:

The Kaplan-Meier cumulative probability of implant survival of the articular surface replacement devices.

Calculating the implant survival for the ASR XL Head device showed a performance of 79% at 60 months and 69% at 96 months. The ASR Resurfacing device showed an implant survival of 90% and 79% at the same time, respectively (Figure 2). The difference in implant survival was not statistically significant (log rank, 0.455).


The implant subgroups (XL head vs resurfacing) with an end point of revision for any reason.

Figure 2:

The implant subgroups (XL head vs resurfacing) with an end point of revision for any reason.

Discussion

Use of large-diameter, MoM devices became a popular and widespread procedure for joint replacement in young and physically active patients due to propagated favorable wear patterns and high range of motion. Nevertheless, within the past few years, the number of revisions for failed hip arthroplasties using MoM articulations increased and there is still an increasing concern regarding possible late effects of systemic metal ion exposure (Table 3).2,6,8,9,12,13,15,16,22,28,29 In particular, the ASR Resurfacing and ASR XL Head systems have been reported to be the worst-performing MoM designs, with higher and steadily increasing revision rates compared to other MoM devices.3,14,30,34 Langton et al34 reported a revision rate up to 49% for the ASR XL Head system and 32% for the ASR Resurfacing component at 6 years (Table 3).


Overview of Published Studies Reporting the Outcome of the ASR Devices

Table 3:

Overview of Published Studies Reporting the Outcome of the ASR Devices

In the current series, there was an unacceptable high overall revision rate of 32% for the ASR XL Head system and 30% for the ASR Resurfacing device after a mean follow-up of 78 and 86 months, respectively. The calculated implant survival was 79% and 90% at 5 years for the ASR XL Head and the ASR Resurfacing systems, respectively. The current results were within the upper limits reported in the literature for revision rates of these devices (Table 3)1,4,23,25,34 but are unacceptably high for modern devices.

There is evidence that the determination of metal ion concentrations in blood, serum, plasma, and urine can be used as surrogate markers for the amount of wear of MoM devices.22,28,35 On the other hand, there are mixed reports concerning the ASR devices with or without increased metal ion concentrations and complication/revision rates.6,14,34,36 It has been shown that the determination of metal ion concentrations may not be sensitive for the detection of ARMD.3,5,6,14,22,24,37–39 Adverse reactions to metal debris subsumes all types of local soft tissue reactions, such as pseudotumors, aseptic lymphocyte-dominated vasculitis-associated lesions, metallosis, corrosive osteolysis, and large sterile hip effusion.2–5,14–16,22,24,27,29

Chang et al14 suggested that abnormal plasma metal ions are not associated with pain or mechanical complications. In addition, these authors found a significant association between high Co concentrations and periprosthetic lucency and ARMD (P<.05), indicating a relation between wear and soft tissue reaction.14

Fox et al3 and Cip et al5 reported discrepancies between pathologies identified on MRI or computed tomography imaging and metal ion levels in the blood, acetabular inclination, and intraoperative findings. Malek et al40 stated that raised metal ion levels do not correlate with the presence of ARMD in symptomatic patients. Macnair et al38 not only confirmed significantly greater periprosthetic tissue reactions with raised Cr levels, but also suggested that ARMD may also be present with normal metal ions.

Reito et al22 recently reported that Co and Cr levels measured in aspirated joint fluid of failed MoM devices had only a poor correlation with the histopathological findings in the tissue samples. Therefore, metal ion determination in joint fluids seems not to be useful and advisable.

The authors performed MARS MRI for 35 of 56 patients, detecting 12 (34%) instances of ARMD. These 12 patients were symptomatic because they presented with pain, noisy devices, or elevated Co and Cr concentrations in the serum. Overall, 3 patients in each group (ASR XL head and ASR resurfacing) had revision surgery based on clinical findings, serum metal ion concentrations, and findings from the MRI.

The inclusion of clinical, laboratory, and radiographic evaluation of all ASR patients treated at the authors' department strengthens the current series. Whitwell et al1 also recently recommended this method of investigation in all ASR patients, even those with well-functioning devices. On the other hand, only patients who had increased metal ion levels or who were symptomatic underwent MRI scanning. Therefore, it can be assumed that the incidence of ARMD would have been higher if all patients had been investigated by cross-sectional imaging, as suggested by Macnair et al.6,38

Increased systemic metal ion exposure with unpredictable long-term consequences is one reason for high revision rates. Many studies showed that metal ion increments are associated with small implant size (<50 mm), malposition (steep inclination with reduced arc of cover and edge loading), and female gender.2,4,6,15,28,41,42 On the other hand, Reito et al30 reported increasing femoral size and stem type as significant risk factors for development of ARMD. Bigger head sizes cause more micromotion at the taper trunnion. Furthermore, Co is preferentially released from the taper-trunnion between the femoral components due to fretting and corrosion.2,4,6,25 This phenomenon could also be observed in the ASR XL head group in the current series.

Reito et al25 and several other authors showed that ASR XL Head device combined with the hydroxyapatite-coated Corail stem or other DePuy stems (S-ROM and Summit) had a higher risk for aseptic loosening, as well as complications associated with ARMD.2,4,23,24,30,34,38 One possible explanation could be third-body wear caused by degradation of the hydroxyapatite coating of the stem and flake release. The authors also observed 3 (7%) cases of aseptic femoral loosening in the ASR XL head group needing revision surgery. However, Cip et al4 recently published a revision rate of 29% for the ASR acetabular cup and the femoral head combined with the CoxaFit or ARGE Geradschaft stems (K-Implant, Hannover, Germany). Therefore, it can be stated that the femoral stem does not directly affect the failure rate and the pattern of impact remains unclear.

There are several limitations in the current study: (1) it is a nonrandomized retrospective review of data collected prospectively, and (2) the authors included patients with unilateral and bilateral hip arthroplasties even though it is debatable whether it is appropriate to include bilateral implants in the survival analysis due to potential confounding effects of a second implant on outcomes and metal ion concentrations in the blood.16 It can be assumed that patients with bilateral hip replacement and an experienced implant associated failure on one side are at an increased risk of failure of the other hip, even if the components were implanted properly.16

Conclusion

Similar to the most recent guidelines from the American Academy of Orthopaedic Surgeons, European Federation of National Associations of Orthopaedics and Traumatology, and British Hip Society, the authors recommend close and annual follow-ups of all MoM THA designs to investigate serum metal ion concentrations for Co and Cr and to obtain plain radiographs. For symptomatic patients with or without elevated metal ion concentrations, MRI should be done once to exclude ARMD. If metal ions are significantly elevated and there is local pain or ARMD confirmed as present on MRI, then revision surgery must be strongly considered. If there are appropriate oriented components and no soft tissue lesions or osteolysis can be detected, careful monitoring is recommended every 6 months.

The current series showed high revision rates for both ASR devices; however, no further revision had to be performed following the first revision surgery. In all cases, press-fit cups could be used for revision surgery with a conventional CoC bearing and a titanium sleeve.

In the future, closer monitoring of new implants and innovations are needed to prevent high failure rates, as in the case of the ASR design. Furthermore, the withdrawal of the device highlights the importance of national implant registries in identifying early device failures.

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  40. Malek IA, King A, Sharma H, et al. The sensitivity, specificity and predictive values of raised plasma metal ion levels in the diagnosis of adverse reaction to metal debris in symptomatic patients with a metal-on-metal arthroplasty of the hip. J Bone Joint Surg Br. 2012; 94(8):1045–1050. doi:10.1302/0301-620X.94B8.27626 [CrossRef]
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Patient Demographics, Failure Rates, Component Details, and Metal Ion Concentrations

VariableOverallASR XL HeadASR ResurfacingPa
Hips, No.644420
Patients, No.563620
Male:female, No.29:2717:1912:8.205
Follow-up, mean (range), mo81 (20–109)78 (20–98)86 (68–109).046
Age at operation, mean (range), y51 (29–68)52 (29–67)49 (33–68).187
Diameter acetabular cup, mean (range), mm53 (44–64)51 (44–58)55 (46–64).003
Femoral head diameter, mean (range), mm47 (39–57)45 (39–51)49 (41–57).003
Serum metal ion concentrations, mean (range), µg/L
  Cobalt18.7 (0–190.5)20.1 (0.3–190.5)16.0 (0–171.8).001
  Chromium12.9 (0.3–125.0)12.8 (1.0–89.8)13.1 (0.31–125.0).006
Revisions, No. of hips19136
Revision rate31%32%30%
Time to revision, mean (range), mo49 (0–83)53 (14–83)40 (0–74)
Failure mode, No. of hips
  Serum metal ion elevation/adverse reactions to metal debris12 (19%)8 (18%)4 (20%)
  Aseptic femoral loosening3 (5%)3 (7%)0
  Infection2 (3%)2 (5%)0
  Cup malposition with subluxation1 (2%)01 (5%)
  Dislocation2 (3%)1 (2%)1 (5%)

Serum Metal Ion Concentrations in the ASR Patients at Prerevision Follow-up

StatusASR XL HeadASR Resurfacing


RevisedNonrevisedRevisedNonrevised
Hips, No.1232614
Serum metal ion concentrations, mean (range), µg/L
  Cobalt54.7 (7.1–190.5)a5.0 (0.3–27.3)a93.4 (0.5–171.8)b1.5 (0–6.0)b
  Chromium30.4 (5.0–89.8)a5.1 (1.0–23.6)a68.8 (0.7–125.0)c2.6 (0.3–10.7)c

Overview of Published Studies Reporting the Outcome of the ASR Devices

StudyRevision RateMetal Ion Concentrations, Mean (Range), µg/LFollow-up, Mean (Range), mo

CobaltChromium
ASR XL Head
  National Joint Registry for England and Wales1913%60
  Hug et al213%14 (0–150)5 (0–87)36 (12–61)
  Steele et al2615%19 (2–41)
  Bernthal et al2317.1%(24–60)
  Langton et al246%3.26 (1.1–32)3.71 (2.4–22)41 (10–57)
  Langton et al3448.8%72
  Lavigne et al360%1.78 (0.32–7.59)1.78 (0.24–6.20)24
  Whitwell et al119%53 (10–80)
  Reito et al2536%Unilateral: 4.2 (0.3–191.7); Bilateral: 13 (1.5–139.9)Unilateral: 2.1 (0.4–115); Bilateral: 3.4 (0.8–61)
  Fernández-Valencia et al150%35 (11–66)
  Current study32%20.1 (0.3–190.5)12.8 (1.0–89.8)78 (20–98)
ASR Resurfacing
  National Joint Registry for England and Wales1912%60
  Hug et al212%12 (0–126)7 (0–60)54 (12–74)
  Jameson et al435.6%43 (30–57)
  Langton et al243.2%2.74 (0.4–271)4.16 (1.5–69.8)35 (8–57)
  Langton et al411.3%1.89 (0.4–228.0)3.61 (0.6–115.0)26 (13–44)
  Langton et al3425%72
  Whitwell et al119%62 (29–80)
  Reito et al2530%Unilateral: 2.3 (0.7–217.7); Bilateral: 2.4 (0.9–96.9)Unilateral: 2.0 (0.8–94); Bilateral: 2.7 (1–54)
  Tibrewal et al44Prerecall: 28%; Postrecall: 36%33; 50
  Fernández-Valencia et al1518.2%35 (11–66)
  Current study30%16.0 (0–171.8)13.1 (0.31–125.0)86 (68–109)
Authors

The authors are from the Department of Orthopaedic Surgery (WME, JF, LAH, LL, KO, MM, AL) and the Institute for Forensic Medicine (KO), Medical University of Graz, Graz, Austria.

The authors have no relevant financial relationships to disclose.

Correspondence should be addressed to: Joerg Friesenbichler, MD, PhD, Department of Orthopaedic Surgery, Medical University of Graz, Auenbruggerplatz 5, 8036 Graz, Austria ( joerg.friesenbichler@medunigraz.at).

Received: August 03, 2016
Accepted: October 31, 2016
Posted Online: December 20, 2016

10.3928/01477447-20161213-04

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