Device was used for treatment, not diagnosis.If information is obtained that was not available for this medwatch, a supplemental medwatch report will be filed as appropriate.The brand name is unknown.The manufacturing location is unknown.The catalog number, lot/serial number, and unique identifier (udi) is unknown.As of this date, the device has not been returned for evaluation; therefore, the reported condition cannot be confirmed and/or duplicated.
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It was reported from (b)(6) that a patient had a total hip replacement surgical procedure using the kincise system (an actis-stem was implanted).It was reported that after the surgery the patient was suffering from a peroneal lesion and a floppy foot.It was reported that the left hip of the patient had been affected.It was reported that an actis rasp size 4 was used, and an actis stem size 4 was implanted.It was not reported if there were any delays in the procedure or if a spare device available for use.There was patient involvement reported.It was not reported what and/or if medical intervention or prolonged hospitalization was required due to this event.There was no allegation of a malfunction against the device.All available information has been disclosed.If additional information should become available, a supplemental medwatch will be submitted accordingly.
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