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 warnings, "improper selection, placement, positioning, alignment and fixation of the implant components may result in unusual stress conditions which may lead to subsequent reduction in the service life of the prosthetic components.".
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This follow-up report is being filed to relay additional information, which was unknown at the time of the initial medwatch.(b)(4).Examination of returned device found no evidence of product non-conformance.Review of the device was unable to confirm the reported complaint.Dimensional analysis found the device to be within specification; therefore, a conclusive root cause for the event could not be determined.
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