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  • ak977 replied to the topic Risk Management in the forum Project Management Process and Medical Device Development 7 years, 5 months ago

    Following up on what bnb6 said, I think that we should also discuss metal-on-metal (MoM) hip replacements and the special risks they carry. In terms of risk management, they are far less likely to be used now because the risks of use are much higher than the average hip replacement.
    For example, additional risks include:
    1. General hypersensitivity reaction (skin rash)
    2. Cardiomyopathy
    3. Neurological changes including sensory changes (auditory, or visual impairments)
    4. Psychological status change (including depression or cognitive impairment)
    5. Renal function impairment
    6. Thyroid dysfunction (including neck discomfort, fatigue, weight gain or feeling cold

    The US FDA, as well as its equivalent in Canada, the UK, and Australia have sent warnings about this device to surgeons to the point that its use has, as it should have, declined severely.