The evaluation was carried out on 03/23/2016 at the manufacturer's service center.Several bolts are used to fix the different parts of the knee joint when it is mounted.The threads of the bolts are covered with an two-component-adhesive, which is hardening once the bolt is tightened.This is to assure that the parts are fixed permanently.The visual evaluation showed two of the bolts in the posterior upper part disengaged and therefore the frame was damaged.No fall or injury occurred due to this failure, but it could have led to patient injury.
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