Dataset Information

Failure Analysis of Retrieved Osteosynthesis Implants.

ABSTRACT: Failure of osteosynthesis implants is an intricate matter with challenging management that calls for efficient investigation and prevention. Using implant retrieval analysis combined with standard radiological examination, we evaluated the main causes for osteosynthesis implant breakdown and the relations among them for a series of cases. Twenty-one patients diagnosed with implant failure were assessed for this work. For metallurgical analysis, microscopy techniques such as scanning electron microscopy (SEM), stereomicroscopy, and optical microscopy were employed. The results showed that material structural deficiencies (nine patients) and faulty surgical techniques (eight patients) were the main causes for failure. An important number of patients presented with material structural deficiencies superimposed on an imperfect osteosynthesis technique (six patients). Consequently, the importance of failure retrieval analysis should not be overlooked, and in combination with other investigational techniques, must provide information for both implant manufacturing and design improvement, as well as osteosynthesis technique optimization.

SUBMITTER: Nica M

PROVIDER: S-EPMC7085058 | biostudies-literature | 2020 Mar

REPOSITORIES: biostudies-literature

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Failure Analysis of Retrieved Osteosynthesis Implants.

Nica Mihai M Cretu Bogdan B Ene Dragos D Antoniac Iulian I Gheorghita Daniela D Ene Razvan R

Materials (Basel, Switzerland) 20200307 5

Failure of osteosynthesis implants is an intricate matter with challenging management that calls for efficient investigation and prevention. Using implant retrieval analysis combined with standard radiological examination, we evaluated the main causes for osteosynthesis implant breakdown and the relations among them for a series of cases. Twenty-one patients diagnosed with implant failure were assessed for this work. For metallurgical analysis, microscopy techniques such as scanning electron mic ...[more]

PMID: 32155981

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Project description:BackgroundMedical devices are used in almost all orthopedic surgical subspecialties, and the frequency of adverse events is increasing, which should not be ignored. To provide suggestions on how to avoid implant recalls from the perspective of manufacturers, medical institutions and supervisions, as well as how to respond promptly to adverse events.MethodsThe research extracted recalls of osteosynthesis implants and joint replacement implants from January 1, 2011, to June 30, 2021, in the CNMPA, FDA, HC and ATGA websites and collected the information on device name, recall time, recall class, recall manufacturer, device classification and affected areas. Moreover, the McKinsey 7S model and fishbone diagram were used to analyze recall reasons.ResultsA total of 315 cases of osteosynthesis implants and 286 cases of joint replacement implants were reported in China, the USA, Canada and Australia. The recalls number from 2016 to 2021 was more than that from 2011 to 2015 for osteosynthesis implant (p = 0.012) and joint replacement implant (p = 0.002), and both mainly focused on class II (76.19% and 78.32%). There were statistical differences in the four countries for both implants (p = 0.000), especially osteosynthesis implant between China and the USA (p = 0.000), China and Canada (p = 0.001), the USA and Australia (p = 0.002), and joint replacement implant between China and Australia (p = 0.000).ConclusionsTo avoid the recalls of such implants, manufacturers should strictly select implant materials and components, develop detailed labels and instructions, severely control the packaging process and establish the integrity of medical device data. Medical institutions should standardize procurement procedures, use qualified equipment and train medical workers. It also requires supervisions to conduct premarket safety assessments. In addition, regulators should strengthen supervision and establish reporting systems to deal with the occurrence of adverse events promptly.

Project description:BACKGROUND:Sonication is a valuable tool in the diagnosis of periprosthetic joint infections (PJI). However, conditions and definition criteria for PJI vary among studies. The aim of this study was to determine the diagnostic performance (i.e., specificity, sensitivity) of sonicate fluid culture (SFC) against periprosthetic tissue culture (PTC), when using European Bone and Joint Infection Society (EBJIS) criteria. METHODS:From March 2017 to April 2018, 257 implants were submitted for sonication. PJI was defined according to the EBJIS criteria as well as according to the International Consensus Meeting criteria of 2018 (ICM 2018). Only cases with at least one corresponding tissue sample were included. Samples were cultured using traditional microbiological plating techniques. Sensitivity and specificity were determined using two-by-two contingency tables. McNemar's test was used to compare proportions among paired samples. Subgroup analysis was performed dividing the cohort according to the site of PJI, previous antibiotic treatment, and time of manifestation. Prevalence of pathogens was determined for all patients as well as for specific subgroups. RESULTS:Among the 257 cases, 145 and 112 were defined as PJI and aseptic failure, respectively. When using the EBJIS criteria, the sensitivity of SFC and PTC was 69.0 and 62.8%, respectively (p =?.04). Meanwhile, the specificity was 90.2 and 92.9%, respectively (p =?.65). When adopting ICM 2018 criteria, the sensitivity of SFC and PTC was 87.5 and 84.4% (p =?.63) respectively, while the specificity was 85.1 and 92.5% (p =?.05), respectively. The most commonly identified pathogens were coagulase-negative staphylococci (26% overall), while 31% of PJI were culture-negative and 9% polymicrobial. CONCLUSIONS:SFC exhibited significantly greater sensitivity versus PTC when using the EBJIS criteria. Nevertheless, the diagnosis of PJI remains a difficult challenge and different diagnostic tools are necessary to optimize the outcome.

Project description:Polyether-ether-ketone (PEEK) has been used clinically for intervertebral fusion and internal fixators in spine and trauma surgery because of its mechanical properties and bioinertness. The present study aimed to assess the suitability of PEEK as an alternative material to cobalt-chromium-molybdenum alloy in total knee arthroplasty (TKA) and evaluate the in vivo wear property on the contact surface of the PEEK-on-highly cross-linked polyethylene (HXLPE). PEEK prosthesis was designed and manufactured using injection molding based on the computed tomography data of a standard goat right hind limb. Fifteen goats underwent TKA using PEEK-on-HXLPE prosthesis on the right hind limb. The goats were sacrificed at 12, 24, and 48 weeks postoperatively. The mean surface roughness (R a) of the retrieved components, proinflammatory cytokines in the synovial fluid, and characteristics of wear particles in the synovial membrane were investigated using laser confocal microscopy, ELISA and polarized light microscopy. The R a of the femoral component was about 0.08, 0.1, 0.2, and 0.26 μm at pre-study, 12-, 24-, and 48 weeks in the retrievals, respectively. The R a of the HXLPE bearing samples was approximately 0.38, 0.4, 0.1, and 0.42 μm at pre-study, 12-, 24-, and 48 weeks in the retrievals, respectively. The median size of the particles was 2.63 μm, 1.98 μm, and 3.00 μm at 12, 24, and 48 weeks, respectively. The particles ranged in size from 0.4 μm to 15 μm, and particles <1 μm accounted for 7-13%, those of size 2-5 μm accounted for 67-76%, and those >5 μm accounted for 11-22%. Levels of interleukin (IL)-6, IL-10, and tumor necrosis factor-α (TNF-α) were significantly increased in synovial fluids at 24- and 48 weeks after surgery. Wear occurred on the surfaces of the PEEK and HXLPE material and the size of most wear particles was 1-5 μm. This induced an inflammatory response in the synovial membrane and release of proinflammatory cytokines. A high polishing process may be necessary to lengthen the life of the PEEK prosthesis by reducing the wear and the generation of debris. The PEEK prosthesis as a new generation of artificial joints is promising to be used clinically in the future.

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Dataset Information

Failure Analysis of Retrieved Osteosynthesis Implants.

Publications

Failure Analysis of Retrieved Osteosynthesis Implants.

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