LFI undertakes expert analysis of failed medical devices and implants in order to identify the cause(s) of failure.
Engineered medical devices and implants are used during medical procedures or are placed on or within the body. Examples of devices and implants include:
- Hip joint prostheses, comprising a femoral stem (e.g. titanium, stainless steel), a femoral head (cobalt alloy, alumina ceramic, polyethylene, etc.) and an acetabular ‘cup’ (ceramic, polyethylene, titanium, etc.)
- Knee joint prostheses, comprising a femoral component (e.g. titanium, cobalt alloy, etc.), an articulating surface (polyethylene) and stemmed tibial plate/tray component (e.g. titanium, cobalt alloy, etc.)
- Locking plates, screws and other fastening components
- Adjustable gastric bands often manufactured from silicone materials
- Catheter lines and tubing
- Implantable Cardioverter defibrillator (ICD) devices to treat heart conditions
Whilst fortunately a rare occurrence, medical devices and implants can fail and LFI applies its expertise to the forensic investigation of such failures, combining detailed examination with relevant testing, microscopic examination and characterisation in order to determine the cause(s) of the issue.
Typical causes or factors may include:
- A materials or manufacturing-related defect, such as contamination, inclusions, voids, casting/moulding/machining defects, etc.
- Mechanical failure, e.g. excessive or unintended loading
- Damage, either occurring before, during or after implantation or use
- Degradation within the body or whilst in use
- Improper design or specification
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