Implantcast (Germany)

In this chapter, the authors proposes an immediate remedy: to teach deaf children a sign language, along with training in speech and speech-reading. For many families, such as those that live far from a Deaf community, as in a rural situation, this presents practical problems. In reality, however, some children who are implanted wind up linguistically deprived. CIs can actually lead to a harm that the Food and Drug Administration in the United States as well as governmental agencies in other countries were not aware existed at the time the devices were approved. In the ideal situation deaf children will be raised with sign language, regardless of their speech-producing and speech-processing skills, so that they will be bilingual in the bimodal sense (i.e. in both a sign language and a written language). Health professionals can help to achieve this ideal situation by properly advising the families of deaf children about the biological nature of first language acquisition.

Abstract The complexity of patient‐specific implants combined with the current limited expertise in reliability engineering and manufacturability in the additive manufacturing (AM) sector is posing a number of quality performance challenges. Worldwide medical device regulatory bodies are facing increasing pressure to devise adequate standards to ensure long‐term patient safety and product performance. The implementation of the Quality by Design (QbD) system to titanium 3D‐printed bone implants offers a proven system to ensure that products are designed and manufactured correctly from the beginning without errors. This article reports on the development of a failure mode, effects, and criticality analysis (FMECA) coupled with a 3D risk assessment approach. This integrated approach is based on a questionnaire performed with three industry firms and three university research groups with significant experience and expertise in medical device product development and/or research in this field. Research outcomes include a FMECA form containing 137 failure modes with AM materials, AM machine general, fabrication, electron beam melting machine, finishing, and design being as the most sensitive process areas in terms of product quality. We subsequently propose corresponding preventive and corrective strategies for risk mitigation. The approach forms part of the QbD system being developed by the authors specifically for additive manufactured titanium patient‐specific implants.

Endoprosthetic reconstruction of massive bone defects has become the reconstruction method of choice after limb-sparing resection of primary malignant tumors of the long bones. Given the improved survival rates of patients with extremity bone sarcomas, an increasing number of patients survive but have prosthetic complications over time. Several studies have reported on the outcome of first endoprosthetic complications. However, no comprehensive data, to our knowledge, are available on the likelihood of an additional complication and the associated risk factors, despite the impact of this issue on the affected patients. (1) What are the types and timing of complications and the implant survivorship free from revision after the first complication? (2) Does survivorship free from repeat revision for a second complication differ by anatomic sites? (3) Is the type of first complication associated with the risk or the type of a second complication? (4) Are patient-, tumor-, and treatment-related factors associated with a higher likelihood of repeat revision? Between 1993 and 2015, 817 patients underwent megaprosthetic reconstruction after resection of a tumor in the long bones with a single design of a megaprosthetic system. No other prosthetic system was used during the study period. Of those, 75% (616 of 817) had a bone sarcoma. Seventeen patients (3%) had a follow-up of less than 6 months, 4.5% (27 of 599) died with the implant intact before 6 months and 43% (260 of 599 patients) underwent revision. Forty-three percent of patients (260 of 599) experienced a first prosthetic complication during the follow-up period. Ten percent of patients (26 of 260) underwent amputation after the first complication and were excluded from further analysis. Second complications were classified using the classification of Henderson et al. to categorize surgical results. Briefly, this system categorizes complications as wound dehiscence (Type 1); aseptic loosening (Type 2); implant fractures or breakage and periprosthetic fracture (Type 3); infection (Type 4); and tumor progression (Type 5). Implant survival curves were calculated with the Kaplan-Meier method and compared using the log-rank test. Hazard ratios (HR) were estimated with their respective 95% CIs in multivariate Cox regression models. A second complication occurred in 49% of patients (115 of 234) after a median of 17 months (interquartile range [IQR] 5 to 48) after the surgery for the first complication. The time to complication did not differ between the first (median 16 months; IQR 5 to 57) and second complication (median 17 months; IQR 5 to 48; p = 0.976). The implant survivorship free from revision surgery for a second complication was 69% (95% CI 63 to 76) at 2 years and 46% (95% CI 38 to 53) at 5 years. The most common mode of second complication was infection 39% (45 of 115), followed by structural complications with 35% (40 of 115). Total bone and total knee reconstructions had a reduced survivorship free from revision surgery for a second complication at 5 years (HR 2.072 [95% CI 1.066 to 3.856]; p = 0.031) compared with single joint replacements. With the numbers we had, we could not show a difference between the survivorship free of revision for a second complication based on the type of the first complication (HR 0.74 [95% CI 0.215 to 2.546]; p = 0.535). We did not detect an association between total reconstruction length, patient BMI, and patient age and survivorship free from revision for a second complication. Patients had a higher risk of second complications after postoperative radiotherapy (HR 1.849 [95% CI 1.092 to 3.132]; p = 0.022) but not after preoperative radiotherapy (HR 1.174 [95% CI 0.505 to 2.728]; p = 0.709). Patients with diabetes at the time of initial surgery had a reduced survivorship free from revision for a second complication (HR 4.868 [95% CI 1.497 to 15.823]; p = 0.009). Patients who undergo revision to treat a first megaprosthetic complication must be counseled regarding the high risk of future complications. With second complications occurring relatively soon after the first revision, regular orthopaedic follow-up visits are advised. Preoperative rather than postoperative radiotherapy should be performed when possible. Future studies should evaluate the effectiveness of different approaches in treating complications considering implant survivorship free of revision for a second complication. Level III, therapeutic study.

Abstract In the present work the influence of phosphor on the flowability, the effect on the infiltration of ZrO2 open foam ceramics and the martensite formation as well as the resulting mechanical properties of high alloyed CrMnNi as‐cast steels is studied. Additionally, the effect of phosphor on surface tension is investigated. The study is performed using thermodynamic calculations, static tensile tests, notch‐bar impact tests, optical light microscopy, scanning electron microscopy, energy dispersive X‐ray analysis, electron backscatter diffraction, and the magnetic scale for the detection of ferromagnetic phase fractions. Maximum bubble pressure method is used to measure the surface tension of the liquid steel. The martensite phase fraction is not significantly influenced with increasing phosphor content. The flowability and the quality of the infiltration of open foam ceramics are improved with increasing phosphor contents. The investigated specimens show an increasing yield and an ultimate tensile strength with higher phosphor contents. The uniform and the fracture elongation as well as the notch impact resistance remain at high values. Moreover, an increase in phosphor content did not significantly change the surface tension of the investigated CrMnNi alloys.