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/or 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." device requested, not yet received.
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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.Review of the device history records indicates the device likely left the manufacturer conforming to print; however, measurements of the returned product were found to be non-conforming, likely due to deformation or damage during unsuccessful attempts to impact the liner.A conclusive root cause of the event could not be determined and the complaint cannot be confirmed.Corrective action has been initiated to address the reported issue.
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