Investigation: no product is at hand.Batch history review: the device history records have been checked and found to be according to the specification valid at the time of production.No similar incidents are filed with products from these batches.Conclusion and root cause: based on the information available, the root cause is most probably user or patient related.An example of a user error could be an implant malfunction due to an insufficiently fixated cone adapter.Based on our experience, micro movements between the neck adapter and the metal stem could facilitate an iron contribution.However, we have not enough information to fully evaluate this case, we do not know if the patient has another prostheses etc.Rational: there are no hints of a product or material deviation.No capa is necessary.
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