It was reported that there was an issue with nk1045t - corehip var cementless 12/14 size 5.According to the complaint description, a bone crack appeared on the medial posterior side when the stem was inserted, but it had not reached the level of the lesser trochanter.Postoperatively, x-rays revealed dislocation.The incision was reopened, but the tendency to dislocate did not completely disappear initially.The dislocation resolved once the head size was changed from l to xl.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, revision surgery.Additional information was not provided nor available.The adverse event is filed under aesculap ag reference no.(b)(4).
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