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 related to the event.There are warnings in the package insert that state that this type of event can occur: under possible adverse effects: "dislocation and subluxation due to inadequate fixation, malalignment, malposition, excessive unusual and/or awkward movement and/or activity, trauma, weight gain, or obesity." this report is number 1 of 2 mdrs filed for the same event (reference 1825034-2014-08938 / 08939).
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