(b)(4).Concomitant medical products: unk, unknown head, unk, unk, unknown cup, unk, unk, unknown liner, unk.Report source, literature - mcgrory, b.Et al (2017).High early major complication rate after revision for mechanically assisted crevice corrosion in metal-on-polyethylene total hip arthroplasty.The journal of arthroplasty, 1-7.Doi: 10.1016/j.Arth.2017.07.004.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 - 2017 - 05677.
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