The review of the device history record showed no deviations.All product features corresponded with the valid specifications of the waldemar link gmbh & co.Kg at the time, when the item was produced.The stem was available for visual examination.A fracture of the stem can be confirmed, this was 150 mm above the stem tip.The investigation has shown that it is a fatigue fracture.The investigations did not reveal material-specific errors.The report is delayed due to inconsistencies with regard to foreign event reporting to fda.After re-evaluation of the complaint we determined that it is reportable.We have addressed the inconsistency in reporting foreign events to fda through capa-(b)(4).
|