It was reported that there was an issue with the product nx752k - e.Motion ps pro fem.Comp.Cemented f4n r.According to the complaint description, the patient experienced a persistent "disabling" inflammatory reaction postoperatively.An allergy consultation was performed which showed sensitivity to several metals.The initial implantation had occurred on (b)(6) 2021.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.Additional information regarding the patient is not available.The adverse event is filed under aesculap ag reference no.(b)(4) (400639121).Associated medwatch-reports: 9610612-2024-00009 (internal aesculap ag ref.No.(b)(4) - nx782k ).(internal aesculap ag ref.No.(b)(4) - nx752k).9610612-2024-00011 (internal aesculap ag ref.No.(b)(4) - nx062k).Involved components: nx924 / e.Motion ps pro men.Comp.F4/f4n r 14mm.Lot: 52495056 (internal aesculap ag ref.No.(b)(4).Nx042 / patella 3-pegs p2.Lot: 52662572 (internal aesculap ag ref.No.(b)(4).
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