It was reported that there was an issue with nk1040t - corehip var cementless 12/14 size 0.According to the complaint description, the implant was inserted in the planned position.Postoperatively, an x-ray showed a fracture.The stability was not effected and the patient was followed-up normally without any complications.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 - reportable malfunction (not later than 30 days).The assessment for the reportability of this malfunction was based on review of the applicable risk analysis.Additional information was not provided nor available.The malfunction is filed under aesculap ag reference no.(b)(4) (400651822).
|