Recall of the ASR XL Head and Hip Resurfacing Systems

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

doi:10.3928/01477447-20161213-04

Cited by 21 publications

(19 citation statements)

References 41 publications

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“…Within the next few years, an increment of bearing-related revisions will be expected, especially in case of MoM THA. Elevated serum metal ion levels and adverse reactions to metal debris (ARMD) will be the main reasons for revision which has been shown in the recent literature [ 16 , 26 , 27 ]. CoM bearings have to be monitored for the same type of failures on the long-run [ 5 ].…”

Section: Discussionmentioning

confidence: 99%

Clinical Results and Serum Metal Ion Concentrations following Ceramic-on-Metal Total Hip Arthroplasty at a Mean Follow-Up of 60 Months

Maurer-Ertl

Pranckh-Matzke

Friesenbichler

et al. 2017

BioMed Research International

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Background. Increased metal ion levels following total hip arthroplasty (THA) with metal-on-metal bearings are a highly debated topic. Local soft tissue reactions with chronic pain and systemic side effects such as neuropathy are described. The aim of the current study was to determine the serum metal ion concentrations of Cobalt (Co) and Chrome (Cr) after THA with a ceramic-on-metal (CoM) bearing. Patients and Methods. Between 2008 and 2010, 20 patients underwent THA using a CoM bearing. Clinical function was evaluated by standardized scores systems (Harris Hip Score and WOMAC Score) and radiological examination included X-rays. Patient's blood samples were obtained for metal ion analysis and correlation analysis was done between these results and implant position. Results. Overall, 13 patients with 14 CoM devices were available for the current series. The mean age at time of surgery was 61 years (range, 41 to 85). The postoperative follow-up ranged from 49 to 68 months (mean, 58). Metal ion determination showed mean concentrations of 3,1 µg/L (range, 0,3–15,2 µg/L) for Co and 1,6 µg/L (range, 0,1–5,5 µg/L) for Cr, respectively. A correlation between cup anteversion and Co and Cr concentrations was shown. Conclusion. The current series showed increments for Co and Cr following CoM THA. However, these levels are lower compared to metal ion concentrations in patients with metal-on-metal bearings and the international accepted threshold for revision of MoM devices. We recommend routine follow-up including at least one obligatory evaluation of serum metal ion concentrations and an MRI once to exclude local soft tissue reactions.

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Section: Discussionmentioning

confidence: 99%

Clinical Results and Serum Metal Ion Concentrations following Ceramic-on-Metal Total Hip Arthroplasty at a Mean Follow-Up of 60 Months

Maurer-Ertl

Pranckh-Matzke

Friesenbichler

et al. 2017

BioMed Research International

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“…2). 1,2,5,6,10 Most of these combined mechanisms increase the extent of corrosion as compared to a single factor or type of mechanism.…”

Section: Combined Mechanisms Of Materials Degradation In-vivomentioning

confidence: 99%

“…Those are influenced by wear, fretting, crevices, fatigue, salts, and inappropriate geometry of implants. [3][4][5][6] Recent findings highlight the importance of inflammatory cells, individual body chemistry, Fenton chemistry, and electrosurgery. 1,[7][8][9][10] In all, it becomes increasingly clear that accelerated corrosion tests or immersion tests in simple solutions (simulating the ionic strength, chloride content, and pH of physiological conditions) are insufficient to predict corrosion observed in-vivo.…”

Section: Introductionmentioning

confidence: 99%

Role of proteins in the degradation of relatively inert alloys in the human body

Hedberg

2018

npj Mater Degrad

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Many biomedical materials used today for applications such as orthopedic, dental, and cardiovascular implants and devices are made of corrosion-resistant, 'inert', metallic materials of the cobalt-chromium, titanium, and stainless steel alloy groups. This perspective focuses on the role of proteins in the degradation of these materials in a human body environment. After adsorption, the proteins interact relatively slowly with the metal and metal surface oxide. A number of factors, including the individual body chemistry (especially the presence of inflammatory cells producing oxidative species), determine whether the proteins can bind to metals in the surface oxide and whether the metal-protein conjugates can detach from the surface. Metals in the forms of proteinbound metal ions or nanosized particles can also increase protein-protein interactions and aggregation, which can cause some health effects and change the material degradation mechanism. While proteins in some short-term studies (<6 h) even decrease material degradation due to shielding effects and better lubrication, they may increase degradation after longer time periods due to relatively slow binding, detachment, and combined corrosion processes. In-vitro material degradation studies of relatively corrosion-resistant alloys for biomedical applications should therefore include long-term studies, complexing agents or proteins, and realistic oxidative environments simulating inflammatory conditions.

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“…The DePuy ASR artificial metal-on-metal hip joint (Articular Surface Replacement) was sold since 2005 to more than 90,000 persons worldwide, and the device was voluntarily recalled by the company in August of 2010 (1, 2). There were reports of higher than normal revision rates for over 1 year before the recall.…”

Section: Recent Adverse Eventsmentioning

confidence: 99%

Improving the Quality of Life of Patients With Medical Devices by a Timely Analysis of Adverse Events

Wyss

2019

Front. Med.

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Implanted and non-implanted medical devices, including artificial joints, are widely accepted to improve the quality of life of patients. While implant survival rates of over 80% can be accepted for artificial joints, there is still a large need to achieve higher survival rates at 15 years or longer to reduce the need for revisions due to implant failure before the end of the patient's life. Therefore, artificial joints are constantly improved with design changes and new designs, including modified or new materials. Most of these improvements perform as expected, but there are still cases where previously unknown failures occur, requiring premature revisions. A few examples of such unsuccessful improvements in the last 20 years are mentioned in this technical case report. The main focus of this paper is on an acetabular cup that was recalled due to unexpected revisions after a few weeks to a few months in vivo . The main reason for the revisions were small amounts of an oily residue containing endotoxins trapped inside the porous coating applied to the cup to facilitate bone ingrowth. The cup was recalled within 4 months after the company become aware of the problem, and prior to knowing exactly why the cups were failing early. The root cause analysis took several more months to complete. The lessons learned during the analysis are discussed so that similar events in other implantable medical devices can be avoided. The acetabular cup case aims to highlight that a timely root cause analysis, triggered by very few unexplained revisions, will benefit patients and improve the quality of life.

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Recall of the ASR XL Head and Hip Resurfacing Systems

Cited by 21 publications

References 41 publications

Clinical Results and Serum Metal Ion Concentrations following Ceramic-on-Metal Total Hip Arthroplasty at a Mean Follow-Up of 60 Months

Clinical Results and Serum Metal Ion Concentrations following Ceramic-on-Metal Total Hip Arthroplasty at a Mean Follow-Up of 60 Months

Role of proteins in the degradation of relatively inert alloys in the human body

Improving the Quality of Life of Patients With Medical Devices by a Timely Analysis of Adverse Events

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