It was reported that there was an issue with the product nk330k - isodur prosthesis head 12/14 22.2mm m.According to the complaint description, the patient underwent a revision surgery on (b)(6) 2024 for an implant replacement due to recurrent dislocation.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.Additional information regarding the patient is not available.The adverse event is filed under aesculap ag reference no.(b)(4).Associated medwatch-reports: (internal aesculap ag ref.No.(b)(4) - nk330k - isodur prosthesis head 12/14 22.2mm m).9610612-2024-00013 (internal aesculap ag ref.No.(b)(4) - nk027k - bipolar cup id22.2mm od47mm self-center.) involved components: nk713t - bicontact sd plasmapore 12/14 size 13mm (internal aesculap ag ref.No.(b)(4).
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