It was reported that there was an issue with the product nk1043t - corehip var cementless 12/14 size 3.According to the complaint description, after the implantation, a breakage of the corehip implant was noticed, hence, a revision surgery was carried out.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) (400651317).
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