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Study Design: Analysis of explanted MAGnetic Expansion Control (MAGEC) growing rods.Objective: The aim of this study was to quantify the rate of locking pin breakage in explanted MAGEC rods and compare with the manufacturer's data.Summary Of Background Data: On June 25, 2019, NuVasive released an Urgent Field Safety Notice stating that MAGEC rods manufactured before March 26, 2015 had a higher than expected locking pin breakage rate of 5%. For rods made on or after that date, no pin breakages had occurred.Methods: From our independent explant database of 139 explanted MAGEC rods supplied from 10 UK spinal centers (Belfast, Bristol, Birmingham, Edinburgh, Exeter, Leeds, Newcastle, Nottingham, Oxford, and Sheffield) and one Danish center (Aarhus), we divided the rods into those manufactured before March 26, 2015, and those manufactured on or after that date. MAGEC rods were cut open to fully assess internal components including locking pins. From each of the two cohorts, 10 locking pins were selected at random and their diameters were measured using a micrometer.Results: One hundred and five explanted MAGEC rods were made before March 26, 2015 and could be disassembled to allow the locking pin to be examined. Fifty-nine percent (62/105) of these locking pins had fractured. For the MAGEC rods manufactured on or after March 26, 2015, 21% (6/29) were found to have fractured locking pins. Locking pins in MAGEC rods made on or after March 26, 2015 were of a stronger material and a larger diameter.Conclusion: Fifty-nine percent of the locking pins in MAGEC rods manufactured before March 26, 2015 had fractured, far greater than the 5% stated in the Urgent Field Safety Notice. Locking pin fracture still occurred in MAGEC rods manufactured on or after that date, in 21% of cases. This contrasted with the 0% reported by the manufacturer.Level Of Evidence: 4. [ABSTRACT FROM AUTHOR]

Total hip replacement with metal-on-polymer hip prostheses is the most common treatment for late-stage osteoarthritis. However, the wear debris generated from the polymer acetabular liner remains a problem. Alternative materials with claimed superior wear properties have been proposed to overcome this problem. In this study, the wear behaviour of carbon fibre reinforced polyether ether ketone (CFR PEEK) was investigated under different contact stresses that are observed in the natural hip joint. A 50-station pin-on-disc machine (SuperCTPOD) was used to investigate the wear behaviour of 50 CFR PEEK pins articulated against cobalt chromium (CoCr) discs under five different contact stresses, namely 1.11, 1.38, 1.61, 2.00 and 5.30 MPa. The results showed that the wear rates of the pins did not differ significantly between groups under different contact stresses. In addition, CFR PEEK produced lower wear rates than ultrahigh molecular weight polyethylene and cross-linked polyethylene. However, the weight of the CoCr discs was found to decrease significantly at the end of the wear test, which was indicative of metallic wear. The findings of this study indicated that, despite having relatively low wear rates, CFR PEEK is not a good alternative to be utilised against orthopaedic metals. [ABSTRACT FROM AUTHOR]

Wear of polyethylene is a current limitation in the long-term survival of reverse shoulder arthroplasties (RSAs). The purpose of this study was to investigate, for the first time, the influence of a combination of clinically relevant activities of daily living (ADLs) as patterns of motion and loading on the wear of ultra-high molecular-weight polyethylene (UHMWPE) in RSA. This physiological combined cycle, termed "repeated-motion-load", was applied on four new samples of a commercially available reverse shoulder prosthesis for five million cycles using the unique Newcastle Shoulder Wear Simulator. This resulted in a mean wear rate of 12.0 ± 3.9 mm3/million cycles for the UHMWPE components in combination with metallic glenospheres, while the average articulating UHMWPE surface roughness reduced from 692 ± 132 nm Sa to 42 ± 29 nm Sa. fx1 [ABSTRACT FROM AUTHOR]

Ceramic‐on‐ceramic (CoC) total hip replacements (THR) have a substantially lower wear rate than metal‐on‐polyethylene (MoP) hips, as shown by hip simulator testing. However, the revision rates of CoC and MoP hips are comparable. To try and explain this discrepancy the wear, at both the bearing surfaces and taper‐trunnion interface of 36 mm BIOLOXdelta CoC THRs, mounted on 12/14 titanium (Ti6Al4V) trunnions was investigated using a hip simulator (n = 3) and a dynamically loaded CoC sample in a separate test station. Wear was assessed gravimetrically and surface roughness measurements of the articulating and taper surfaces taken at regular intervals. Scanning electron microscopy, surface roughness, and gravimetric measurements of trunnions was performed. After 5 million cycles, the mean total wear from the ceramic articulating surfaces was 0.25 mm3 from the hip simulator test, and that from the titanium trunnions was 0.29 mm3. This metal wear may provide an explanation for adverse reaction to metal debris found in contemporary CoC hip joints. It is therefore vital to consider taper‐trunnion wear in preclinical testing of artificial hip joints. © 2018 Wiley Periodicals, Inc. J Biomed Mater Res Part B: Appl Biomater 107B: 1199–1209, 2019. [ABSTRACT FROM AUTHOR]

Generation of wear debris and wear particle-induced osteolysis are the main limitations of metal-on-polyethylene artificial joints. Cross-linked polyethylene has been recently used, particularly in hip replacements, as an alternative material to conventional ultrahigh molecular weight polyethylene due to its superior wear resistance. This study focused on the wear behaviour of cross-linked polyethylene under different contact stresses in order to make interpretations of its long-term in-vivo performance. A 50-station SuperCTPOD (pin-on-disc) machine was used to investigate the influence of contact stress on the wear of cross-linked polyethylene pins which were articulated against cobalt chromium discs. It was found that the wear rate of cross-linked polyethylene was lower at higher contact stresses. [ABSTRACT FROM AUTHOR]

Study Design: Analysis of explanted MAGnetic Expansion Control (MAGEC) growing rods.Objective: To analyze explanted MAGEC rods used in management of early onset scoliosis and identify the mode of failure in such cases.Summary Of Background Data: Magnetically controlled growing rods are increasingly used as the option of choice for early onset scoliosis. However, being more complex than conventional growing rods they are perhaps more likely to succumb to multifarious failure modes. In addition, metallosis has been reported around failed MAGEC rods.Methods: Explanted MAGEC rods from seven UK spinal centers were obtained for independent analysis. Thirty-four MAGEC rods, from 18 children, explanted for reasons including failure of rod lengthening and maximum rod distraction reached, were cut open to allow internal components to be evaluated and assessed.Results: Externally, all MAGEC rods showed localized marks, which were termed "growth marks" as they indicated growth of the rod in vivo, on the extending bar component. After cutting open, titanium wear debris was found inside all 34 (100%) MAGEC rods. Ninety-one percent (31/34) of MAGEC rods showed measurable wear of the extending bar, towards the magnet end. Substantial damage to the radial bearing was seen inside 74% (25/34) of MAGEC rods while O-ring seal failure was seen in 53% (18/34) of cases. In 44% (15/34) of MAGEC rods the drive pin was fractured but this was felt to be an effect of rod failure, not a cause.Conclusion: The combination of high volumes of titanium wear debris alongside O-ring seal damage likely accounts for the metallosis reported clinically around some MAGEC rods. Based on this explant data, a failure mechanism in MAGEC rods due to the natural off axis loading in the spine was proposed. This is the largest data set reporting a complete analysis of explanted MAGEC rods to date.Level Of Evidence: 4. [ABSTRACT FROM AUTHOR]

Artificial finger joints lack the long-term clinical success seen with hip and knee prostheses. In part, this can be explained by the challenges of rheumatoid arthritis, a progressive disease which attacks surrounding tissues as well as the joint itself. Therefore, the natural finger joints' biomechanics are adversely affected, and consequently, this imbalance due to subluxing forces further challenges any prosthesis. Many different designs of finger prosthesis have been offered over a period of greater than 50 years. Most of these designs have failed, and it is likely that many of these failures could have been identified had the prostheses been appropriately tested prior to implantation into patients. While finger joint simulators have been designed, arguably only those from a single centre have been able to reproduce clinical-type failures of the finger prostheses tested in them. This article describes the design and development of a finger simulator at Durham University, UK. It explains and justifies the engineering decisions made and thus the evolution of the finger simulator. In vitro results and their linkage to clinical-type failures are outlined to help to show the effectiveness of the simulator. Failures of finger implants in vivo continue to occur, and the need for appropriate in vitro testing of finger prostheses remains strong. [ABSTRACT FROM AUTHOR]

This work aimed to engineer a multi-station shoulder simulator in order to wear test shoulder prostheses using recognized shoulder activities of daily living. A bespoke simulator was designed, built and subject to commissioning trials before a first wear test was conducted. Five JRI Orthopaedics Reverse Shoulder VAIOS 42 mm prostheses were tested for 2.0 million cycles and a mean wear rate and standard deviation of 14.2 ± 2.1 mm(3)/10(6) cycles measured for the polymeric glenoid components. This result when adjusted for prostheses diameters and test conditions showed excellent agreement with results from hip simulator studies of similar materials in a lubricant of bovine serum. The Newcastle Shoulder Simulator is the first multi-station shoulder simulator capable of applying physiological motion and loading for typical activities of daily living. [ABSTRACT FROM AUTHOR]

A recognized issue related to metal-on-metal hip resurfacings is early fracture of the femur. Most theories regarding the cause of fracture relate to clinical factors but an engineering analysis of failed hip resurfacings has not previously been reported. The objective of this work was to determine the wear volumes and surface roughness values of a cohort of retrieved hip resurfacings which were removed due to early femoral fracture, infection and avascular necrosis (AVN). Nine resurfacing femoral heads were obtained following early fracture of the femur, a further five were retrieved due to infection and AVN. All fourteen were measured for volumetric wear using a co-ordinate measuring machine. Wear rates were then calculated and regions of the articulating surface were divided into "worn" and "unworn". Roughness values in these regions were measured using a non-contacting profilometer. The mean time to fracture was 3.7 months compared with 44.4 months for retrieval due to infection and AVN. Average wear rates in the early fracture heads were 64 times greater than those in the infection and AVN retrievals. Given the high wear rates of the early fracture components, such wear may be linked to an increased risk of femoral neck fracture. [ABSTRACT FROM AUTHOR]

Bovine serum is the lubricant recommended by several international standards for the wear testing of orthopaedic biomaterials; however, there are issues over its use due to batch variation, degradation, cost and safety. For these reasons, alternative lubricants were investigated. A 50-station Super-CTPOD (circularly translating pin-on-disc) wear test rig was used, which applied multidirectional motion to ultra-high-molecular-weight polyethylene test pins rubbing against cobalt chromium discs. Thirteen possible alternative lubricants were tested. The use of soy protein as a lubricant gave statistically higher wear, while soya oil, olive oil, Channel Island milk, whole milk, whey, wheatgerm oil, 11 mg/mL egg white, albumin/globulin mix and albumin/globulin/chondroitin sulphate mix all gave statistically lower wear than bovine serum. The lubricants giving the closest wear results to bovine serum were 20 and 40 mg/mL egg white solutions. A light absorbance assay found that these egg white solutions suffered from a high degradation rate that increased with increasing protein content. While egg white solutions offer the best alternative lubricant to bovine serum due to the wear volumes produced, cost-effectiveness and safety of handling, protein degradation will still occur, leading to the need for regular lubricant replacement. Of the lubricants tested in this study, none were found to be superior to bovine serum. [ABSTRACT FROM PUBLISHER]

Using a 50-station pin-on-disc (SuperCTPOD) machine, the influence of lubricant viscosity on the wear of vitamin E blended crosslinked polyethylene was investigated. Five different test lubricants were prepared by mixing different concentrations of carboxymethyl cellulose powder with deionised water. The viscosity range of the lubricants was 0.002–0.155 Pa, a range that represents the viscosities of diseased and healthy synovial fluids. Five groups of pins (10 pins in each group) were articulated against cobalt chromium discs. Wear was measured in terms of weight loss from each pin and disc for every group. Every 500,000 cycles the experiment was stopped to take gravimetric measurements along with roughness measurements of the articulating surfaces. The test discs did not show a significant change in weight after 2.5 million cycles of testing (p > 0.05). For the pins, the group tested with the lowest viscosity (0.002 Pa) produced the highest wear rate, namely 0.931 mg/million cycles, and the wear rates of the other groups were 0.074, 0.027, 0.034 and 0.021 mg/million cycles respectively. The wear rates calculated for the five groups were all lower than the wear rates recorded for ultrahigh molecular weight polyethylene and not significantly different to crosslinked polyethylene. In addition, apart from group 1 pins (tested with the lowest lubricant viscosity (0.002 Pa)), the machining marks on the other pins were still present after 2.5 million cycles of testing, indicating low wear. [ABSTRACT FROM AUTHOR]