(b)(6).Concomitant products: unknown head p/n unknown l/n unknown; unknown stem p/n unknown l/n unknown, unknown cup p/n unknown l/n; unknown liner p/n unknown l/n unknown.Multiple mdr reports were filed for this event.Please see reports: 0001825034-2017-05582, 0001825034-2017-05583, 0001825034-2017-05584, 0001825034-2017-05585.Reported event was unable to be confirmed.Device history record (dhr) review was unable to be performed as the item and lot number of the device involved in the event is unknown.Root cause could not be determined as the necessary information to adequately investigate the reported event was not provided.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.Sillesen, nanna h., greene, meridith e., nebergall, audrey k., huddleston, james i., emerson, roger, gebuhr, peter, troelsen, anders, malchau, henrik (2015).Three-year follow-up of a long-term registry-based multicenter study on vitamin e diffused polyethylene in total hip replacement.Hip international, vol 26 issue 1, pages 1-104http://www.Hip-int.Com/article/3-year-follow-up-of-a-long-term-registry-based-multicentre-study-on-vitamin-e-diffused-polyethylene-in-total-hip-replacement.Not returned to manufacturer.
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