{"id":16836,"date":"2019-09-06T15:45:31","date_gmt":"2019-09-06T14:45:31","guid":{"rendered":"https:\/\/www.hawkins.biz\/?post_type=insight&p=16836"},"modified":"2025-08-06T17:03:02","modified_gmt":"2025-08-06T16:03:02","slug":"an-analysis-of-failed-biomaterials","status":"publish","type":"insight","link":"https:\/\/www.hawkins.biz\/insight\/an-analysis-of-failed-biomaterials\/","title":{"rendered":"An Analysis of Failed Biomaterials"},"content":{"rendered":"\t\t
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WHAT IS A BIOMATERIAL?<\/span><\/h4>

A biomaterial is a structure that can be used to replace or augment body parts such as bone, teeth, ligaments, cartilage or heart valves.\u00a0<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t

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Common biomaterials include: polymers, ceramics, glass-ceramics, stainless steels, and titanium alloys.\u00a0 Biomaterials are classified both according to their biocompatibility (ease of acceptance within the human body) and their mechanical properties, such as: tensile\/compressive\/shear strength, hardness, toughness, and fatigue resistance.\u00a0<\/p>

When designing a biomaterial, the material specifications are dictated by the, mechanical, physiological, and shape requirements of the original tissue that needs to be replaced.\u00a0 Hard composite tissue, such as bone, tends to be replaced by metals and ceramics, whilst softer connective tissue, such as tendons or ligaments, tends to be replaced by polymeric materials.<\/p>

The most common example of biomaterial today is the total hip replacement (THR), which was first invented in 1962 by Sir John Charnley in the UK.\u00a0 THR is a prosthesis that people often receive by the time they reach 50 – 70 years of age.\u00a0 The Charnley prosthesis was constructed of stainless steel, whilst modern day prostheses are commonly titanium alloy-based, as the material is strong, lightweight and more biocompatible.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t

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The Charnley Prosthesis: Image from the Welsh Museum of Health & medicine<\/figcaption>\n\t\t\t\t\t\t\t\t\t\t<\/figure>\n\t\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t
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Modern day THR<\/figcaption>\n\t\t\t\t\t\t\t\t\t\t<\/figure>\n\t\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t
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\u00a0<\/p>

The main reasons for receiving a THR prosthesis are trauma, osteoarthritis, osteoporosis, and\/or wear and tear.\u00a0 Whichever the scenario, the hip pain generated from an insufficient articulating joint can be excruciating, and having a THR surgically implanted can both eliminate pain and increase durability of the joint for a set number of years, depending on the patient\u2019s age and planned further activity. \u00a0For example, a 50 year old with a freshly implanted THR, who exercises for one hour every day, may require a revision surgery, whereby the THR is replaced after 10 -15 years.\u00a0 However, a 65 year old who goes walking for only 10 minutes per day may never require a revision surgery.<\/p>

Biomaterials are designed by materials engineers who have an expert knowledge of human anatomy and physiology. However, a basic understanding of the principles of biomaterials and biomechanics has not only become a prerequisite for practising orthopaedic surgeons, but also forms an important component in the education of orthopaedic trainees. \u00a0Biomechanics is a sub-branch of the general field of mechanics and, as such, it embraces the fundamental principles of this discipline and applies them to the human body. A biomaterial can only be considered suitable for implantation if it will withstand loads generated both internally and externally; the field of biomaterials can therefore only propagate and evolve if orthopaedic surgeons and materials engineers continue to collaborate and share knowledge.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t

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Examples, of known species that cause stress corrosion cracking and the metals they affect are:<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t

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HOW & WHY BIOMATERIALS FAIL<\/span><\/h4>

A biomaterial, much like any other engineering material, can fail in a multitude of ways; the most common failures are attributed to poor design, poor installation, failing to meet material specifications, and operational wear.<\/p>

The design of an optimum biomaterial, amongst other things, requires consideration of the material\u2019s mechanical properties and biocompatibility.\u00a0 The mechanical property which defines the stiffness of a biomaterial is called the elastic modulus (EM).\u00a0 If the EM of the biomaterial does not match the EM of the original tissue it is replacing, the implant may fail.\u00a0 For example, following implantation surgery of a total hip replacement, if the metal alloy used in the construction of the THR is stiffer than that of the surrounding bone (i.e. an EM mis-match), then as the load is absorbed to a greater extent in the implant, the surrounding bone will begin to breakdown and resorb into the bloodstream.\u00a0 This phenomena is called stress-shielding.\u00a0 As a result of the loss of bone integrity, gaps will appear in the interface between the implant and the bone, causing the implant to move in-vivo (within the patient\u2019s body), and such instability can lead to catastrophic failure.\u00a0<\/p>

When a THR fails in-vivo, which is frightening and potentially excruciating, the patient will require revision surgery to remove and replace the implant.\u00a0 Revision surgeries are expensive, not just in terms of equipment\/surgeon\u2019s fees, but also in terms of the patient\u2019s time lost due to physical recovery.\u00a0 As such, it is best to avoid shortcomings during the initial design and material choice for the implant, given the impact they can have on both the patient and the healthcare provider.<\/p>

Engineering Fatigue<\/strong><\/span><\/p>

One of the most common failure mechanisms for metal biomaterials is engineering fatigue[1]<\/a>[2]<\/a>.\u00a0 Fatigue is a phenomenon that occurs, in the presence of cyclic (or repeated) loading, whereby a material may fail at stress levels below the static yield stress.\u00a0 (A yield stress, which can be either static or dynamic, is calculated in proportion to how far that material, such as a replacement hip joint, can be stretched).\u00a0 Fatigue testing of materials involves cyclically loading the material at different stress levels until failure occurs. \u00a0A plot of stress vs number of cycles of loading, called the SN curve, identifies the value of stress below which fatigue will not occur; this is called the fatigue endurance limit.<\/p>

In designing metal implants for use in the body, it is important to ensure that the stress levels encountered are below this endurance limit to avoid failure. \u00a0Fatigue failures of metal implants occur particularly in the stress raisers\/stress concentrations in the implant.\u00a0 Stress raisers are geometric features that raise the local concentration of stress in a structure; they can be features of the design, such as screw holes in fracture plates, or defects, notches or scratches in the implant. \u00a0Even the presence of a screw hole in a bone after removal of a fracture plate can precipitate a stress concentration-related fracture of the bone.\u00a0<\/p>

Engineering Wear<\/strong><\/span><\/p>

Another common failure in softer biomaterials is engineering wear[3]<\/a>.\u00a0 This type of failure involves two uneven surfaces articulating past each other, releasing wear particles that facilitate the abrasion, and eventual failure, of one or more surfaces, as shown in the below failure of the polymeric component of a total knee replacement:<\/p>

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Total Knee Replacement having failed due to wear in the polyethylene component<\/figcaption>\n\t\t\t\t\t\t\t\t\t\t<\/figure>\n\t\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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The manner in which the damage presents itself, albeit its abrasion or cracking, can be assessed by a materials engineer in order to determine the failure mechanism.\u00a0 For example, the manner in which cracks propagate, and the subsequent fracture surfaces are distinguishable and highly characteristic.\u00a0 Therefore, the failure mode can be identified with the assistance of either low or high power microscopy.\u00a0 Mechanical tests can also be conducted in order to determine if the failed biomaterial met its engineering specifications, and chemical analysis can indicate if the biomaterial was manufactured to the required grade.\u00a0 With this information, the materials engineer can then determine if the incident occurred as a result of improper implantation, manufacturing defects, design deficiencies, operation damage, abuse by the patient, or the use of defective, non-biocompatible materials.\u00a0<\/p>

ABOUT THE AUTHOR<\/span><\/h4>

Dr Sophie Parsons<\/a> is a Chartered Engineer (CEng) and a Fellow of the Institute of Materials, Minerals, and Mining (MIMMM). \u00a0Dr Parsons can provide advice on determining the failure mode of ceramic, plastic, and metal biomaterials. She has provided expertise and conducted investigations involving glass, ceramic, and rubber materials failure analysis incidents in Hawkins\u2019 Hong Kong Office for 7 years until relocating to the United Kingdom. She is currently based in London.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t

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[1]<\/a> Murphy BP, Prendergast PJ, \u201cOn the magnitude and variability of the fatigue strength of acrylic bone cement<\/em>\u201d, International Journal of Fatigue, 22: 855-864, 2000.<\/p>

[2]<\/a> Jeffers JRT, Browne M, Lennon AB, Prendergast PJ, Taylor M, \u201cCement mantle fatigue failure in total hip replacement: Experimental and computational testing<\/em>\u201d, Journal of Biomechanics, 40: 1525-1533, 2007.<\/p>

[3]<\/a> Affato S, Spinelli M, Zavalloni M, Mazzega-Fabbro C, Viceconti M, \u201cTribology and total hip joint replacement: Current concepts in mechanical simulation<\/em>\u201d, Medical Engineering & Physics, 30: 1305 – 1317, 2008.<\/p>

\u00a0<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t<\/div>\n\t\t","protected":false},"excerpt":{"rendered":"

An Analysis of Failed Biomaterials: Biomaterials replace bone or heart valves. Types include polymers, ceramics, stainless steels, and titanium alloys.<\/p>\n","protected":false},"featured_media":16838,"parent":0,"template":"","insight_category":[],"experties":[68],"class_list":["post-16836","insight","type-insight","status-publish","has-post-thumbnail","hentry","experties-materials-chemistry-biology"],"acf":[],"yoast_head":"\nFailed Biomaterials: Forensic Analysis & Lessons Learned<\/title>\n<meta name=\"description\" content=\"Learn how forensic engineers analyse failed biomaterials used in medical devices and implants to determine causes and prevent recurrence.\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/www.hawkins.biz\/insight\/an-analysis-of-failed-biomaterials\/\" \/>\n<meta property=\"og:locale\" content=\"en_GB\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Failed Biomaterials: Forensic Analysis & Lessons Learned\" \/>\n<meta property=\"og:description\" content=\"Learn how forensic engineers analyse failed biomaterials used in medical devices and implants to determine causes and prevent recurrence.\" \/>\n<meta property=\"og:url\" content=\"https:\/\/www.hawkins.biz\/insight\/an-analysis-of-failed-biomaterials\/\" \/>\n<meta property=\"og:site_name\" content=\"Hawkins Forensic Investigation\" \/>\n<meta property=\"article:modified_time\" content=\"2025-08-06T16:03:02+00:00\" \/>\n<meta property=\"og:image\" content=\"https:\/\/www.hawkins.biz\/wp-content\/uploads\/2022\/12\/MAIN-IMAGE_AdobeStock_126371081_830x630.jpeg\" \/>\n\t<meta property=\"og:image:width\" content=\"830\" \/>\n\t<meta property=\"og:image:height\" content=\"630\" \/>\n\t<meta property=\"og:image:type\" content=\"image\/jpeg\" \/>\n<meta name=\"twitter:card\" content=\"summary_large_image\" \/>\n<meta name=\"twitter:label1\" content=\"Estimated reading time\" \/>\n\t<meta name=\"twitter:data1\" content=\"7 minutes\" \/>\n<script type=\"application\/ld+json\" class=\"yoast-schema-graph\">{\"@context\":\"https:\/\/schema.org\",\"@graph\":[{\"@type\":\"WebPage\",\"@id\":\"https:\/\/www.hawkins.biz\/insight\/an-analysis-of-failed-biomaterials\/\",\"url\":\"https:\/\/www.hawkins.biz\/insight\/an-analysis-of-failed-biomaterials\/\",\"name\":\"Failed Biomaterials: Forensic Analysis & Lessons Learned\",\"isPartOf\":{\"@id\":\"https:\/\/www.hawkins.biz\/#website\"},\"primaryImageOfPage\":{\"@id\":\"https:\/\/www.hawkins.biz\/insight\/an-analysis-of-failed-biomaterials\/#primaryimage\"},\"image\":{\"@id\":\"https:\/\/www.hawkins.biz\/insight\/an-analysis-of-failed-biomaterials\/#primaryimage\"},\"thumbnailUrl\":\"https:\/\/www.hawkins.biz\/wp-content\/uploads\/2022\/12\/MAIN-IMAGE_AdobeStock_126371081_830x630.jpeg\",\"datePublished\":\"2019-09-06T14:45:31+00:00\",\"dateModified\":\"2025-08-06T16:03:02+00:00\",\"description\":\"Learn how forensic engineers analyse failed biomaterials used in medical devices and implants to determine causes and prevent recurrence.\",\"breadcrumb\":{\"@id\":\"https:\/\/www.hawkins.biz\/insight\/an-analysis-of-failed-biomaterials\/#breadcrumb\"},\"inLanguage\":\"en-GB\",\"potentialAction\":[{\"@type\":\"ReadAction\",\"target\":[\"https:\/\/www.hawkins.biz\/insight\/an-analysis-of-failed-biomaterials\/\"]}]},{\"@type\":\"ImageObject\",\"inLanguage\":\"en-GB\",\"@id\":\"https:\/\/www.hawkins.biz\/insight\/an-analysis-of-failed-biomaterials\/#primaryimage\",\"url\":\"https:\/\/www.hawkins.biz\/wp-content\/uploads\/2022\/12\/MAIN-IMAGE_AdobeStock_126371081_830x630.jpeg\",\"contentUrl\":\"https:\/\/www.hawkins.biz\/wp-content\/uploads\/2022\/12\/MAIN-IMAGE_AdobeStock_126371081_830x630.jpeg\",\"width\":830,\"height\":630,\"caption\":\"Hip replacement implant installed in the pelvis bone. 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