Current information is insufficient to permit a conclusion as to the cause of the event.Review of device history records show that lot released with no recorded anomaly or deviation.There are warnings in the package insert that state that this type of event can occur: under possible adverse effects, number 5 states, "material sensitivity reactions." number 12 states, "dislocation and subluxation due to inadequate fixation, malalignment, malposition, excessive unusual and/or awkward movement and/or activity, trauma, weight gain, or obesity.Muscle and fibrous tissue laxity can also contribute to these conditions." number 15 states, "wear and/or deformation of articulating surfaces.".
|