Current information is insufficient to permit a conclusion as to the cause of the event.Review of device history records show the lot released with no recorded anomaly or deviation.(b)(6).There are warnings in the package insert that state that this type of event can occur: under possible adverse effects, number 5 states, "dislocation has been reported with two-stage revisions." this report is number 1 of 3 mdrs filed for the same patient (reference 1825034-2016-03484, 03485 and 03490).Remains implanted.
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