It was reported that there was an issue with nk1045t - corehip var cementless 12/14 size 5.According to the complaint description, during implantation a femoral bone fracture occurred.The procedure was finished successfully by wiring around the fracture.The postoperative course was uneventful and there were no complications.There had been a difference of about 3mm in the insertion depth between the rasp and the stem.Possibility of over-sizing.According to manufacturer's reporting evaluation in accordance with 21 cfr part 803, section 803.3, this event is considered reportable for the following reason - adverse event (not later than 30 days).The assessment for the reportability of this adverse event was based on the patient harm, additional medical intervention.Additional information was not provided nor available.The adverse event is filed under aesculap ag reference no.(b)(4).
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