It was reported that there was an issue with nu213t - excia t plasmapore 12/14 size 13mm.According to the complaint description, the surgeon complains about the too tight head / conus connection in the exciat: intraoperatively, he had to change a used s head to an l head after reduction.Despite all his efforts, the stem came along with itwhen it was cut off.He then implanted a new 13 mm shaft and an l head.An additional medical intervention was necessary.Additional information was not provided nor available / was not available.The adverse event is filed under aag reference (b)(4).Associated medwatch-reports: 9610612-2021-00373, (b)(4) + nk650d).
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Updated h6: codes.Based upon investigation results, this event was re-evaluated and is considered no longer reportable due to risk file- no malfunction or serious injury.Investigation results: visual investigation: the provided hip implant components show no deviation or abnormalities.The provided components were examined visually and microscopically.Furthermore this case was discussed with a specialist from the product management.In the delivered condition the nk650d -> biolox delta prosth.Head 12/14 36mm s is still fixed on the nu213t -> excia t plasmapore 12/14 size 13mm.The cone connection of both components shows no abnormalities.Batch history review: the device quality and manufacturing history records have been checked for the available lot number and were found to be according to our specifications valid at the time of production.Review of the complaint history revealed that no similar complaints have been filed against products from this batch number.Conclusion and measures / preventive measures: based upon the investigation results a clear root cause conclusion cannot be drawn.There is no indication for a material-, manufacturing- or design-related failure.Based upon the investigations results a capa is not necessary.
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