Analysis of Failed Biomaterials

A biomaterial is a structure that can be used to replace or augment part of the human body. Common biomaterials are contact lenses, knee and hip replacements (Figures 1 and 2). The material specifications are dictated by the shape, mechanical and physiological requirements of the original tissue. Hard composite tissue such as bone can be replaced by metals and ceramics, and softer connective tissue such as tendons and ligaments can be replaced by polymeric materials. The design of an optimum biomaterial, amongst other things, requires consideration of mechanical properties and biocompatibility. The mechanical property, which defines the stiffness of a biomaterial is called the elastic modulus (EM). If the EM of the biomaterial does not match the EM of the original tissue that it is replacing, the implant may fail. Likewise, if the material is not biocompatible an inflammatory response may be elicited, possibly leading to loosening or rejection of the implant. Similarly, design flaws can lead to uneven load distributions on the implant. Such design shortcomings may lead to premature failure of the biomaterial possibly necessitating revision surgery.
Figure 2 Total Hip Replacement. Figure 1 Total Knee Replacement.

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One of the most common failure mechanisms for metal biomaterials is fatigue. Over time, cyclic loading of the material can cause cracks to propagate and the material to fracture before the end of its engineering lifespan (Photograph 1). Another common failure in softer biomaterials is engineering wear. This 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 failure of the polymeric portion of a total knee replacement (Photograph 2).

Photograph 1 Broken Hagie Pin shown here in the treatment of a fractured clavicle.

Photograph 2 Worn polyethylene component from a total knee replacement.

The ways in which cracks propagate are characteristic and as a result can be used to identify the specific failure mechanism. Mechanical tests can be carried out to determine if the failed material met its original engineering specifications and chemical analysis shows if the material was manufactured to the required grade Once the failure mechanism is identified, the analyst can determine the cause of the failure, for example, investigating why a hip implant failed in-vivo. The cause may be due to improper implantation, manufacturing defects, design deficiencies, operational damage, abuse by the patient or the use of defective, non-biocompatible materials.

Hannaford Forensic Services has been conducting independent investigations for over 20 years and employs a team of experienced and qualified forensic engineers and scientists. Please contact one of the team to discuss the range of materials and biomaterials failure investigation services that we can offer. Tel (24 hrs): +852 2548 0577

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