It was reported that there was an issue with the product nk1005t - corehip std cementless 12/14 size 5.According to the complaint description, postoperatively, bilateral trochanteric fractures were noted.These occurred after total hip arthroplasties (tha).During revision surgery, the long stem was replaced and wiring applied.Hospitalization was extended.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 / malfunction is filed under aesculap ag reference no.(b)(4)((b)(4)).Associated medwatch reports: nk1004t/ 9610612-2024-00124 (aesculap ag reference no.(b)(4)).
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