Vorkommnisse bei Hüft- und Knieendoprothesen

Heinz, B.; Mallek, D. von

doi:10.1007/s00132-004-0708-2

Cited by 14 publications

(4 citation statements)

References 17 publications

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“…Cases of material failure in the form of chipping or breakage are very rare. The failure rates of ceramic ball heads in ceramic self-pairing designs are reported between 0.004 % and 0.06 % [8,9,13,24,27] . Internal statistics of the Mathys Orthopaedie GmbH (Moersdorf/Thuer., Germany) signify failure rates of ceramic ball heads of 0.03 % for head diameter of 28 mm and 0.008 % for head diameter of 32 mm.…”

Section: Introductionmentioning

confidence: 98%

“…Some reasons for fracture are indicated after fall of the patients, other fractures occur while walking without trauma [8 -10, 12, 15, 17 -19, 20] . It is assumed that many of these failures without trauma could have been prevented with careful intraoperative handling [7,13,26] . Some case reports with ceramic head fracture postulate damaged cones or contaminations within the connection area as reason for breakage [14,18,19] .…”

Section: Introductionmentioning

confidence: 99%

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Influence of various types of damage on the fracture strength of ceramic femoral heads

Wuttke

Witte

Kempf

et al. 2011

Biomedizinische Technik/Biomedical Engineering

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Ceramic-on-ceramic articulations are a frequently used bearing for total hip replacements. This success mainly is due to their excellent tribological properties. Ceramics can withstand high pressure loads due to its brittleness but only low bending stresses. A ceramic ball head fracture is the result of subcritical crack growth. This kind of fracture in vivo can abet by damage or contamination of the stem cone. The main goal of this work is to provide a risk assessment of different possible damage mechanisms and contaminations that may result in lower fracture strength of a ceramic ball head. To simulate potential causes, different types and dimensions of metal wire, foils, hair, and lubricants were inserted between the ceramic ball head and the metal cone of the stem. The test results clearly show that fracture strength is negatively influenced by most of the inhomogeneities between the cone and the head because they increase the peak stresses acting on a part of the ceramic ball head. The results of this article clearly confirm the demand for an undamaged taper fit "free of contamination" between the ceramic head and the metal cone during implantation.

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Section: Introductionmentioning

confidence: 98%

Section: Introductionmentioning

confidence: 99%

Influence of various types of damage on the fracture strength of ceramic femoral heads

Wuttke

Witte

Kempf

et al. 2011

Biomedizinische Technik/Biomedical Engineering

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“…"Die gesamte Fallbearbeitung unterliegt aufgrund der gesetzlichen Vorgaben der Vertraulichkeit. Auf die Nennung von Hersteller-oder Produkteigennamen muss daher durchgehend verzichtet werden, es sei denn, es handelt sich um bereits anderweitige oder aus Gründen der Risikoabwehr veröffentlichte und allgemein zugängliche Tatsachen" [19]. Da die ausgewerteten Daten aus einem Spontanerfassungssystem stammen, erfolgt aufgrund der Vielschichtigkeit der Meldungen eine beschreibende statische Auswertung.…”

Section: Introductionunclassified

Vorkommnismeldungen bei mechanischen Herzklappenprothesen

Mallek

Heinz²,

Löffler³

et al. 2008

Dtsch med Wochenschr

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The Medical Devices Vigilance System is able to detect product failures of mechanical heart valves and to initiate corrective action. As the reporting rate over more than 10 years is relatively low, it can be assumed that in general mechanical heart valves are safe medical devices. The quality of incident reporting by manufactures and users of medical devices should be improved to reduce the number of undetected and unsolved incidents.

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“…Die Dunkelziffer bei den Meldungen ist groß. So sind beispielsweise für den Zeitraum vom 01.01.2000 bis zum 31.12.2002 insgesamt lediglich 274 Vorkommnismeldungen im Zusammenhang mit Hüft-und Kniegelenkprothesen beim BfArM eingegangen, während die Zahl der im gleichen Zeitraum tatsächlich durchgeführten Wechseleingriffe wesentlich hö-her war[34].Bei den bisher vorliegenden Kohortenstudien zur Ergebnisqualität in der Endoprothetik finden sich verschiedene Verzerrungen (Bias). Ihre Resultate zu Komplikationen weichen teilweise um das mehrfache von den entsprechenden Angaben in bereits bestehenden validen Registern ab[35] und sind daher nicht auf die Grundgesamtheit über-tragbar[35][36][37].…”

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Register als Werkzeug für mehr Endoprothesensicherheit

Hassenpflug

Liebs

2014

Bundesgesundheitsbl.

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There has previously been no structured long-term documentation of the results of hip and knee prosthesis operations in Germany. This article presents the objectives, structure and data flow of the newly established German arthroplasty registry (EPRD). The EPRD is run as a subdivision of the German Society for Orthopedics and Orthopedic Surgery (Deutsche Gesellschaft für Orthopädie und orthopädische Chirurgie, DGOOC). It is dedicated to scientific principles and guarantees independency and immediate feedback to surgeons. The cooperation between insurance funds, hospitals, industry and scientific society is the key to success. Additional data acquisition and bureaucratic formalities are limited to a minimum and in particular there is no use of paper. Involving the health insurance funds provides access to relevant routine data. The implant documentation is facilitated by means of an implant library and barcode scanning in the operating room. The EPRD documents the survival of implants including the reasons for revision. Although the highest level of patient data protection is guaranteed, individual patients can be identified in case of implant recalls.

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Vorkommnisse bei Hüft- und Knieendoprothesen

Cited by 14 publications

References 17 publications

Influence of various types of damage on the fracture strength of ceramic femoral heads

Influence of various types of damage on the fracture strength of ceramic femoral heads

Vorkommnismeldungen bei mechanischen Herzklappenprothesen

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