It was reported that there was an issue with nk1002t - corehip std cementless 12/14 size 2.According to the complaint description, during total hip arthroplasty (tha) surgery, a bone "crack" on the medial side of the femur occurred while inserting and hammering.The surgeon then replaced the stem with a non-aesculap cement stem.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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