Analysing a mechanism of failure in retrieved magnetically controlled spinal rods.

PURPOSE: We aim to describe a mechanism of failure in magnetically controlled growth rods which are used for the correction of the early onset scoliosis. METHODS: This retrieval study involved nine magnetically controlled growth rods, of a single design, revised from five patients for metal staining, progression of scoliosis, swelling, fractured actuator pin, and final fusion. All the retrieved rods were radiographed and assessed macroscopically and microscopically for material loss. Two implants were further analysed using micro-CT scanning and then sectioned to allow examination of the internal mechanism. No funding was obtained to analyse these implants. There were no potential conflicts interests. RESULTS: Plain radiographs revealed that three out of nine retrieved rods had a fractured pin. All had evidence of surface degradation on the extendable telescopic rod. There was considerable corrosion along the internal mechanism. CONCLUSIONS: We found that a third of the retrieved magnetically controlled growth rods had failed due to pin fracture secondary to corrosion of the internal mechanism. We recommend that surgeons consider that any inability of magnetically controlled growth rods to distract may be due to corrosive debris building up inside the mechanism, thereby preventing normal function.

Fretting and Corrosion Between a Metal Shell and Metal Liner May Explain the High Rate of Failure of R3 Modular Metal-on-Metal Hips.

BACKGROUND: The R3 acetabular system used with its metal liner has higher revision rates when compared to its ceramic and polyethylene liner. In June 2012, the medical and healthcare products regulatory agency issued an alert regarding the metal liner of the R3 acetabular system. METHODS: Six retrieved R3 acetabular systems with metal liners underwent detailed visual analysis using macroscopic and microscopic techniques. RESULTS: Visual analysis discovered corrosion on the backside of the metal liners. There was a distinct border to the areas of corrosion that conformed to antirotation tab insertions on the inner surface of the acetabular shell, which are for the polyethylene liner. Scanning electron microscopy indicated evidence of crevice corrosion, and energy-dispersive X-ray analysis confirmed corrosion debris rich in titanium. CONCLUSION: The high failure rate of the metal liner option of the R3 acetabular system may be attributed to corrosion on the backside of the liner which appear to result from geometry and design characteristics of the acetabular shell.

Clinical Cold Welding of the Modular Total Hip Arthroplasty Prosthesis.

BACKGROUND: A head that is "clinically cold welded" to a stem is one of the commonest reasons for unplanned removal of the stem. It is not clear which hip designs are at greatest risk of clinical cold welding. METHODS: This was a case-control study of consecutively received hip implant retrievals; we chose the design of hip that had the greatest number of truly cold-welded heads (n = 11). For our controls, we chose retrieved hips of the same design but without cold welding of the head (n = 35). We compared the clinical variables between these 2 groups using nonparametric Mann-Whitney tests to investigate the significance of differences between the cold-welded and non-cold-welded groups. RESULTS: The design that most commonly caused cold welding was a combination of a Ti stem and Ti taper: 11 out of 48 (23%) were truly cold welded. Comparison of the clinical data showed that no individual factor could be used to predict this preoperatively with none of the 4 predictors tested showing any significance: (1) time to revision (P = .687), (2) head size (P = .067), (3) patient age at primary (P = .380), and (4) gender (P = .054). CONCLUSION: We have shown that clinical cold welding is most prevalent in Ti-Ti combinations of the stem and taper; approximately 25% of cases received at our center were cold welded. Analysis of clinical variables showed that it is not possible to predict which will be cold welded preoperatively. Surgeons should be aware of this potential complication when revising a Ti-Ti stem/head junction.

Damage Patterns at the Head-Stem Taper Junction Helps Understand the Mechanisms of Material Loss.

BACKGROUND: Material loss at the taper junction of metal-on-metal total hip arthroplasties has been implicated in their early failure. The mechanisms of material loss are not fully understood; analysis of the patterns of damage at the taper can help us better understand why material loss occurs at this junction. METHODS: We mapped the patterns of material loss in a series of 155 metal-on-metal total hip arthroplasties received at our center by scanning the taper surface using a roundness-measuring machine. We examined these material loss maps to develop a 5-tier classification system based on visual differences between different patterns. We correlated these patterns to surgical, implant, and patient factors known to be important for head-stem taper damage. RESULTS: We found that 63 implants had "minimal damage" at the taper (material loss <1 mm3), and the remaining 92 implants could be categorized by 4 distinct patterns of taper material loss. We found that (1) head diameter and (2) time to revision were key significant variables separating the groups. CONCLUSION: These material loss maps allow us to suggest different mechanisms that dominate the cause of the material loss in each pattern: (1) corrosion, (2) mechanically assisted corrosion, or (3) intraoperative damage or poor size tolerances leading to toggling of trunnion in taper.

The Relationship Between Cobalt/Chromium Ratios and the High Prevalence of Head-Stem Junction Corrosion in Metal-on-Metal Total Hip Arthroplasty.

BACKGROUND: The size of the clinical impact of corrosion of the taper junction of metal-on-metal total hip arthroplasties (MOM-THAs) is unclear. Examination of a large number of retrieved MOM resurfacings and total hip arthroplasties can help us understand the role of taper corrosion in metal ion release. METHODS: We graded the severity of corrosion at the taper junction of 395 MOM-THAs and compared the prerevision whole blood metal ion levels of these hips with 529 failed MOM hip resurfacings. RESULTS: Virtually all MOM-THA hips (n = 388) had evidence of corrosion of the head-stem taper junction and graded as severe in 31% (n = 124). The median cobalt/chromium (Co/Cr) ratio was 1.58 (0.01-13.82) and 1.08 (0-4.86) for MOM-THA and MOM hip resurfacing, respectively; this difference was significant (P < .001). THA hips with severely corroded tapers had the highest median Co/Cr ratio of 1.86 (0.01-10). CONCLUSIONS: This study demonstrates the high prevalence of severe taper corrosion, which may be related to an elevated Co/Cr ratio before revision.

Clinical significance of corrosion of cemented femoral stems in metal-on-metal hips: a retrieval study.

PURPOSE: The clinical significance of corrosion of cemented femoral stems is unclear. The purpose of this retrieval study was to: (1) report on corrosion at the stem-cement interface and (2) correlate these findings with clinical data. METHODS: We analysed cemented stems (n = 36) composed of cobalt-chromium (CoCr) and stainless steel (SS) in a series of revised metal-on-metal hips. We performed detailed inspection of each stem to assess the severity of corrosion at the stem-cement interface using a scale of 1 (low) to 5 (severe). We assessed the severity of corrosion at each stem trunnion and measured wear rates at the head taper and bearing surfaces. We used non-parametric tests to determine the significance of differences between the CoCr and SS stems in relation to: (1) pre-revision whole blood Co and Cr metal ion levels, (2) trunnion corrosion, (3) bearing surface wear and (4) taper material loss. RESULTS: The corrosion scores of CoCr stems were significantly greater than SS stems (p < 0.01). Virtually all stem trunnions in both alloy groups had minimal evidence of corrosion. The median pre-revision Co levels of implants with CoCr stems were significantly greater than the SS stems (p < 0.01). There was no significant difference in relation to pre-revision Cr levels (p = 0.521). There was no significant difference between the two stem types in relation to bearing wear (p = 0.926) or taper wear (p = 0.148). CONCLUSIONS: Severe corrosion of cemented femoral stems is a common finding at our retrieval centre; surgeons should consider corrosion of CoCr stems as a potential source of metal ions when revising a hip.

Corrosion of Metal Modular Cup Liners.

Numerous studies have reported on corrosion at the modular head taper, however less is known about the interface between the metal shell and liner of modular cups. This study examined the backside of a series of metal modular cup liners of two designs (DePuy Pinnacle and Smith & Nephew R3), retrieved from 67 patients. Visual inspection found evidence of corrosion in virtually all liners, with the engaging rim surface significantly more corroded than the polar regions (P<0.001). EDX confirmed that black surface deposits were chromium rich corrosion debris, while SEM analysis revealed considerable pitting in the vicinity of the black debris. The R3 liners were significantly more corroded that the Pinnacles (P<0.001); this may help to explain the higher revision rates of this design.

The reliability of a scoring system for corrosion and fretting, and its relationship to material loss of tapered, modular junctions of retrieved hip implants.

It has been suggested that corrosion and fretting at the tapered, modular junctions of hip arthroplasties may contribute to implant failure. In this study the reliability of a commonly used peer-reviewed scoring system for visual assessment of corrosion and fretting at these junctions was evaluated. Volumetric material loss at the tapered head surface was measured and associations with the visual scores were investigated. We found that the inter-observer reproducibility and single-observer repeatability of the corrosion scores were substantial using Cohen's weighted Kappa statistic (k = 0.64-0.71). The reproducibility and repeatability of the fretting scores however were slight to fair (k = 0.18-0.31). Taper corrosion scores were significantly and moderately correlated with the volume of material loss measured (Spearman's r = 0.59; P < 0.001). We recommend the continued use of this scoring system but it should not be a substitute for measurement of material loss.

Component size mismatch of metal on metal hip arthroplasty: an avoidable never event.

Size mismatch of components used in total hip arthroplasty is a serious, preventable patient safety incident of unknown prevalence as many cases are not detected. Component size mismatch was found in 11 cases (0.9%) at our retrieval centre. All cases of mismatch were not detected on plain radiograph during routine clinical follow up and blood metal ion levels were elevated above the MHRA action level of 7 ppb. Root cause analysis identified manufacturer, hospital and surgeon factors that need to be addressed to reduce the incidence of this avoidable clinical problem. Retrieval analysis is the only method of confirming size mismatch and is likely to be under-represented in National Joint Registries that record the indication for revision at the time of revision.

Variation in taper surface roughness for a single design effects the wear rate in total hip arthroplasty.

Material loss from the head-stem taper junction of total hip arthroplasty (THA) is implicated in adverse reactions to metal debris (ARMD); the mechanisms for this are multi-factorial. We investigated the relationship between the roughness of the "as manufactured" taper surface and the wear rate from this junction. Fifty retrieved Pinnacle metal-on-metal (MOM) bearings paired with a Corail stem were included in the study. Multivariable statistical analysis was performed to determine the influence of taper roughness on material loss rate after controlling for other confounding surgical, implant, and patient factors. The surface roughness of the "as manufactured" head taper surface was associated with the rate of material loss from this surface. Four of eighteen roughness variables taken from ISO 4,287 and ISO 13,565-2 were significant: The Reduced Peak Height (Rpk, the protruding peaks above the core) (p = 0.004), Material Ratio 1 (Mr1, the ratio of the protruding peaks above the core) (p = 0.002), Area of the Peak Region (A1, the area of the Abbott-Curve that contains the peaks from the profile) (p = 0.003) and the Skewness (Rsk, the asymmetry of the height distribution corresponding to the height or depth of surface features) (p = 0.03). We found a large variability in the measured values with a median (range) of 0.50 (0.05-2.98), 11.98 (0.46-39.98), 30.89 (0.15-581.00), and 0.04 (-0.73-0.84), respectively. A 1-unit increase in Rpk was associated with a 73% increase in the taper wear rate. The variability of "as manufactured" surface roughness has a significant effect on taper material loss. © 2016 Orthopaedic Research Society. Published by Wiley Periodicals, Inc. J Orthop Res 35:1784-1792, 2017.

Clinical relevance of corrosion patterns attributed to inflammatory cell-induced corrosion: A retrieval study.

In vitro studies have shown that human osteoclasts can corrode stainless steel and titanium leading to the production of metal ions responsible for inflammatory reactions. Moreover, traces of cellular activities on metal orthopaedic explants have recently been reported as inflammatory cell-induced (ICI) corrosion being the result of the cells sealing on the metal surfaces and releasing reactive oxygen species (ROS) through Fenton-like reactions. The extent and clinical relevance of this phenomenon has yet to be understood. We analysed a cohort of 100 CoCr alloy hips collected at our retrieval centre; we performed macroscopic and microscopic screening and used statistical analysis to correlate our findings with implant and clinical variables. We found that 59% of our implants had evidence of surface damage consistent with what has previously been described as cell-induced corrosion. There was a significant association between the patterns and aseptic loosening for the ASR modular (r = -0.488, p = 0.016) and the Durom modular (r = 0.454, p = 0.026). This is the largest implant retrieval study to examine the phenomena of so-called ICI corrosion and is the first to investigate its clinical relevance. We recommend further work to determine the role of cells in the damage patterns observed. © 2015 Wiley Periodicals, Inc. J Biomed Mater Res Part B: Appl Biomater, 105B: 155-164, 2017.

Detailed inspection of metal implants.

Detailed visual inspection of metal hips is the first step in retrieval analysis. In this study a systematic visual inspection protocol was developed to quantify bearing surface changes and their associations with material loss was investigated. Simple and multiple linear regression models found that moderate surface scratching, discolouration, haziness and the size of visible wear scars were all significantly associated with material loss (R2 = 5%-73%, p<0.05). Visual inspection is not a substitute for measurement of material loss but an understanding of bearing surface changes may offer unique clues as to the mechanisms of failure of retrieved hips.

Influence of stem type on material loss at the metal-on-metal pinnacle taper junction.

The clinical importance of material loss at the head-stem junction is unknown. Comparison of retrievals with different stem types can provide the opportunity to understand the importance of the taper junction. This was a case-control study involving 20 retrieved 36 mm metal-on-metal Pinnacle (DePuy) hips that were paired with either a Corail (n = 10) or S-ROM (n = 10) stem. The median head taper material loss rate for the Corail group was 0.238 (0.0002-2.178) mm(3)/year and was significantly greater than the S-ROM group (p = 0.042), which had a median material loss rate of 0.132 (0.015-0.518) mm(3)/year. The only significant difference between the groups was the stem taper roughness and length: this was rougher and shorter for the Corails. Long and smooth stem taper designs are preferred when used in conjunction with metal heads.