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Background: Although the Pinnacle Acetabular Hip System (DePuy Synthes) has demonstrated excellent survivorship results since it was first introduced in 2003, there have been a growing number of cases indicating that Pinnacle liners may be subject to a higher-than-expected rate of early dissociation failure. Between 2006 and 2020, our Centre received 212 retrieved Pinnacle liners from Western Australian hospitals. Of these, 26 were removed due to liner dissociation. Methods: To better understand the frequency and cause of this complication we assessed all retrieved Pinnacle acetabular components for type, damage modes and patient demographics. The leverage force required to dissociate Pinnacle liners was also measured and compared with another commonly used acetabular system, the Trident (Stryker Orthopaedics). Results: The estimated minimum incidence of liner dissociation from our data was 0.35%. Characterisation of dissociated Pinnacle cases (n = 26) revealed 73% were female with an average age of 59 compared to all retrieved Pinnacle cases (n = 212) where 58% were female with an average age of 66. Retrieval analysis indicated plastic deformation of the liner into an ovoid shape, signs of impingement on the rim postero-superiorly and shearing of the liner’s anti-rotation tabs was common. Mechanical testing indicated that the dissociation strength of Pinnacle cups decreases at approximately 6.6 N/year in situ (p = 0.01). Conclusion: The survival rate of Pinnacle acetabular cups is exceptional with only 5% revised at 10 years. However, surgeons should be aware of the clinical symptoms and high-risk demographics when assessing patients with polyethylene Pinnacle liners.

Aims The aim of this study was to conduct the largest low contact stress (LCS) retrieval study to elucidate the failure mechanisms of the Porocoat and Duofix femoral component. The latter design was voluntarily recalled by the manufacturer. Materials and Methods Uncemented LCS explants were divided into three groups: Duofix, Porocoat, and mixed. Demographics, polyethylene wear, tissue ingrowth, and metallurgical analyses were performed. Results In 104 implants, a decrease in the odds of loosening and an increase in metallosis and tissue staining in the Duofix group relative to Porocoat group was detected (p = 0.028). There was an increased presence of embedded metallic debris in the Duofix group (p < 0.001). Decreased tissue ingrowth was associated with the Duofix surface (p < 0.001). The attached beads had reduced microhardness, indicative of adverse thermal processing, which resulted in bead shedding, particulate debris, and metallosis. Conclusion Hydroxyapatite coating of the LCS femoral component produced unexpected results and led to its recall. The root cause was likely a combination of retained alumina grit and a reduction in bead microhardness (mechanical strength) resulting in increased particle debris, metallosis, and early revision. The Duofix LCS femoral component was not equivalent to the Porocoat version despite its approval through the Food and Drug Administration (FDA) 510(k) equivalance approval process. Regulation of the introduction of modified existing devices needs to be improved and the Duofix LCS should have been considered to be a new device for which equivalence had not been demonstrated at the point of introduction. Cite this article: Bone Joint J 2019;101-B:1248–1255

Mechanical failure of intramedullary nails is rare. This investigation was prompted by a series of cases of observed breakage of the recently introduced TFNA Proximal Femoral Nailing System (TFN [Trochanteric Fixation Nail]-Advanced; DePuy Synthes) in our region. Laboratory analysis and case data are presented, in contribution to post-market surveillance.Medical and imaging records from the 3 public tertiary orthopaedic trauma hospitals in Western Australia were reviewed. Relevant data of patients in whom breakage of the TFNA implant occurred between 2016 and 2018 were collected and analyzed. Laboratory review of retrieved implants was conducted at the Centre for Implant Technology and Retrieval Analysis (CITRA) in Western Australia.A total of 16 cases of TFNA implant breakage were recorded and analyzed. The predominant OTA/AO fracture classification was 31A3 (12 cases, 75%). The reduction quality was good in 10 cases, acceptable in 4 cases, and poor in 2 cases. The mean time to failure (and standard deviation) was 5.0 ± 2.2 months (range, 2.2 to 9.8 months). The treatment modality for the breakage was revision nailing in 11 cases, arthroplasty in 3, and nonoperative management in 2. All nails broke at the proximal screw aperture, with 1 nail additionally breaking at the distal aperture. Of 8 patients treated with a second TFNA implant for nail breakage, 3 (38%) returned with breakage of the revision implant. Laboratory analysis of the broken nails demonstrated a unique fracture pattern, with a stepped propagation pathway.This study represents the largest series, to our knowledge, of proximal femoral nail breakages in the published English literature and is the first that we are aware of to involve laboratory analysis of the TFNA implant. Changes to the nail design and/or alloy may have contributed to the observed cases of breakage, and this study will be followed by an evaluation of breakage rates in comparison with those of previous generations of nailing systems. We advise close clinical and radiographic surveillance of patients with unstable hip fracture patterns who undergo osteosynthesis with use of a TFNA implant.Therapeutic Level IV. See Instructions for Authors for a complete description of levels of evidence.

While modular femoral heads have been used in THA for decades, a recent innovation is a second neck-stem taper junction. Clinical advantages include intraoperative adjustment of leg length, femoral anteversion, and easier revision, all providing flexibility to the surgeon; however, there have been reports of catastrophic fracture, cold welding, and corrosion and fretting of the modular junction.We asked whether (1) the neck-stem junction showed the same degradation mechanisms, if any, as the head-neck junction, (2) the junction contributed to THA revision, (3) the alloy affected the degree of degradation, and (4) the trunion machine finish affected the degradation mechanisms.We compared 57 retrievals from seven total hip modular designs, three cobalt-chromium-molybdenum and four titanium based: Bionik(®) (four), GMRS(®) (four), Margron(®) (22), Apex(®) (five), M-series(®) (five), ZMR(®) (two), and S-ROM(®) (15). Macroscopic inspection, microscopy, and micro-CT were conducted to determine the effects of materials and design.The cobalt-chromium-molybdenum components showed crevice corrosion and fretting of the neck-stem taper, whereas the titanium components had less corrosion; however, there were several cases of cold welding where disassembly could not be achieved in theater.Even with modern taper designs and corrosion-resistant materials, corrosion, fretting, and particulate debris were observed to a greater extent in the second neck-stem junction. Titanium-based modular arthroplasty may lessen the degree of degradation, but cold welding of the components may occur.Degradation of the second junction contributed to 8 cases of metallosis and two cases of aseptic lymphocyte-laminated vascular-associated lesions contributing to revision.

Femoral component neck fracture is an uncommon type of failure in total hip arthroplasty. We present a report on 4 retrieved cobalt-chrome femoral components that fractured at the neck, where we investigated the mechanisms of failure.The 4 retrieved implants were analyzed with regard to their macro- and microstructures and the fracture surfaces were examined using electron microscopy. The medical record of each patient was also examined for any history of complications prior to failure of the implant.These fractures occurred immediately adjacent to the base of the modular head. Skirted modular heads were used in 3 of the 4 failed components. This constructs promotes corrosion. Cyclic fatigue-loading in combination with the material factors of course grain microstructure and extensive carbide precipitation along the grain boundaries were also identified as the cause of implant failure.Our findings suggest that a solution annealing step could be introduced into the manufacturing process to improve the microstructure of the cobalt chrome alloy. We also advise caution in using a skirted modular head in combination with a device of known suboptimum microstructure, for a greater margin of safety.

Routine qualitative observations of more than 850 polyethylene fixed and mobile bearings at our institution have noted minimal wear of mobile bearings. The APG mobile bearing is the most recent design variant of the LCS knee, allows multi-directional movement at the tibiofemoral articulation, and is posterior cruciate sparing. Even though it is difficult to perform, quantitative wear measurement is important in determining the likely longevity of new arthroplasty devices, and is especially relevant because of increasing numbers of new mobile bearing designs.We analyzed 10 retrieved APG and 7 retrieved RP tibial bearings (De Puy) with a mean implantation period of 33 (9-70) months. We used coordinate-measuring techniques to quantitatively determine linear penetration, and optical and scanning electron microscopy to assess wear mechanisms qualitatively.The mean total volume loss (superior and inferior articulations) of the APG and RP designs was 85 mm((3))/year and 77 mm((3))/year, respectively. Burnishing was the predominant wear mechanism, and to a lesser extent scratching, abrasion and pitting. Multidirectional scratching and abrasion were noted on the APG inserts inferiorly, whereas there was circumferential scratching on the RP inserts.Our short-term results for the APG and RP mobile bearing designs are similar and compare more than favorably with reported values for fixed-bearing designs. However, increased backside wear due to multidirectional movement may predispose the APG design to greater wear in the long term.

Background Many exchangeable neck hip systems have been withdrawn because of fretting corrosion at the neck/stem coupling. Method Our prospective randomized study evaluating stem stability (Roentgen stereophotogrammetric analysis, dual-energy x-ray absorptiometry) and clinical outcomes between the K2/Apex hip systems was ceased early because of a withdrawal of the stems which had an unfavorably high early revision rate reported in the Australian Orthopaedic Association National Joint Registry (9.3% at 3 years). Results At 2 years, there are no clinical differences between the stems. Roentgen stereophotogrammetric analysis has identified a high proportion of potentially concerning subsidence and retroversion in both groups, more marked in the K2 stem, although mostly in asymptomatic patients. Dual-energy x-ray absorptiometry has shown similar bone density around the stems. Retrieval analysis of 3 study patients showed fretting corrosion of the antirotation pin and aseptic lymphocyte-dominated vasculitis-associated lesion, with no relationship to bearing type or size. Analysis of 7 further nonstudy K2/Apex stems confirmed similar corrosion. Conclusion This study shows potentially concerning subsidence of both stems and is the first to describe corrosion at the neck-stem interface and a relationship to metal-related pathology.

Poly Implant Prothèse implants were recalled in Australia in April of 2010 following concerns of higher than expected rupture rates and the use of unauthorized industrial grade silicone as a filler material. Although subsequent investigations found that the gel filler material does not pose a threat to human health, the important question of what caused a relatively modern breast implant to have such a poor outcome compared with contemporary silicone breast implants is yet to be addressed.From a cohort of 27 patients, 19 ruptured Poly Implant Prothèse breast implants were subjected to a range of mechanical tests and microscopic/macroscopic investigations to evaluate possible changes in properties as a result of implantation. New Poly Implant Prothèse implants were used as controls.All samples, explanted and controls, complied with the requirements for shell integrity as specified in the International Organization for Standardization 14607. Compression testing revealed rupture rates similar to those reported in the literature. Shell thickness was highly variable, with most shells having regions below the minimum thickness of 0.57 mm that was specified by the manufacturer. Potential regions of stress concentration were observed on the smooth inner surfaces and outer textured surfaces.The high incidence of Poly Implant Prothèse shell rupture is most likely a result of inadequate quality control, with contributory factors being shell thickness variation and manufacturing defects on both inner and outer surfaces of the shell. No evidence of shell degradation with implantation time was determined.

Bead shedding has been reported in both hip and knee arthroplasties and can result in increased polyethylene wear and metal ion release. The rates of bead loss were recorded for each device type, and the interfacial bead-substrate shear load to failure and contact areas of the beads were determined. The 3 components with the highest rate of bead loss, namely, S-Rom, Omnifit, and Optifix acetabular shells, recorded the lowest shear loads to failure. Percentage bead-substrate contact area ranged between 7% and 37% and was the most important factor affecting bead shedding. Other factors influencing bead loss in decreasing order of importance were bead fusion, bead size, component type (acetabular or knee), component loosening, and time in situ.

Six fractured high nitrogen stainless steel (HNSS), polished, tapered hip stems have been reviewed for analysis. Clinical data suggests that poor proximal support (loosening), varus positioning, and canal morphology are implicated in the failure of these stems. Metallurgical assessment reveals a number of microstructural deficiencies contributing to failure. Of significance is poor grain homogeneity and larger grain size near the surface of the fractured stems. It appears some polished, tapered HNSS stems are at risk when combinations of these clinical and metallurgical features occur. As the control of grain size, microstructural uniformity, and inclusion content are critical for optimum mechanical performance, it is important the manufacturers review processing methods to further minimize the risk of component failure.

Oxinium exhibits 4900 times less volumetric wear and 640 times less deep scratches in laboratory wear testing compared with traditional cobalt-chromium alloys. Despite the superior wear resistance because of the thin ceramic surface, the zirconium alloy substrate is relatively soft (Hv = 285) when compared with cobalt-chrome alloy femoral heads (ISO 5832-12; Hv = ~420,) and may deform in contact with acetabular shell materials (ISO5832-3; Hv = 350) in the case of dislocation. Three retrieval cases highlight the damage that may occur during dislocation and/or when performing closed reduction maneuvers. It is recommended that closed reduction be attempted with caution because significant head damage can occur. This may lead to accelerated polyethylene wear. In the case of successful reduction, close patient follow-up is recommended. Open reduction with femoral head inspection and exchange may be preferable if difficulty is encountered in closed reduction maneuvers.