(b)(4).Date of death - unknown.Date approximately seven years post-initial total elbow arthroplasty.Concomitant medical product: unknown, unknown humeral stem, unknown.Report source, foreign - the event occurred in (b)(6).Report source, literature - ernstbrunner, l.Et al (2018).Long-term results of total elbow arthroplasty in patients with hemophilia.Journal of shoulder and elbow surgery, 27(1), 126-132.Doi: 10.1016/j.Jse.2017.09.009.Reported event was unable to be confirmed due to limited information received from the customer.Device history record (dhr) review was unable to be performed as the lot number of the device involved in the event is unknown.Root cause was unable to be determined.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.Multiple mdr reports were filed for this event, please see associated reports: 0001822565-2018-01001; 0001822565-2018-01002; 0001822565-2018-01016; 0001822565-2018-01017.Product location unknown.
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It was reported in a journal article that one patient developed a late periprosthetic infection in a previously implanted unknown knee after a joint bleed.The periprosthetic infection further became complicated into the patient's bilateral implanted elbows.Due to periprosthetic infection, with the identified primary source of the knee, the polyethylene and pins were exchanged in the total elbow systems.The patient subsequently died of sepsis seven years after the initial bilateral total elbow arthroplasty.No further information has been provided concerning the reported event.
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