(b)(4).Customer has indicated that the product will not be returned to zimmer biomet for investigation, as the product location is unknown.Initial surgery occurred in 2016.Revision surgery occurred in 2016.Concomitant products: item number: unknown, item name: unknown cup, lot #: unknown; item number: unknown, item name: unknown neck, lot #: unknown; item number: unknown, item name: unknown liner, lot #: unknown; item number: 00771300700, item name: femoral stem, lot #: 60825861.Multiple mdr reports were filed for this event, please see associated reports: 0001822565 - 2018 - 03906.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
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It was reported patient underwent hip revision due to osteolysis and necrosis.During revision fluid, osteolysis, necrosis, and metallosis were noted.Liner and head were removed and replaced.Attempts have been made and no additional information is available.
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